Methods of adjusting therapy in a patient having an endolumenal bypass to treat obesity

ABSTRACT

The present invention provides devices and methods for attachment of an endolumenal gastrointestinal device, such as an artificial stoma device, a gastrointestinal bypass sleeve device or an attachment cuff, within a patient&#39;s digestive tract for treatment of obesity.

CROSS Reference TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 11/124634 filed May 5, 2005 which claims the benefit of U.S.provisional patent application 60/569,442, filed on May 7, 2004, byKagan et al. for Devices and Methods for Treating Morbid Obesity andU.S. provisional patent application 60/613,917, filed on Sep. 27, 2004,by Kagan et al. for Devices and Methods for Attachment of aGastrointestinal Sleeve. This patent application is also acontinuation-in-part of U.S. utility patent application Ser. No.10/698,148, filed on Oct. 31, 2003 by Kagan et al. for Apparatus andMethods for Treatment of Morbid Obesity which claims priority to U.S.provisional patent applications 60/480,485, 60/448,817, 60/437,513,60/430,857, 60/428,483, and 60/422,987. This patent application is alsoa continuation-in-part of U.S. utility patent application Ser. No.10/998,424, filed on Nov. 29, 2004 by Kagan et al. for Apparatus andMethods for Treatment of Morbid Obesity and of U.S. utility patentapplication Ser. No. 11/025,364, filed on Dec. 29, 2004, by Kagan et al.for Devices and Methods for Treating Morbid Obesity. The devices andmethods described herein can be combined with and/or used in conjunctionwith the apparatus and methods described in these prior applications.These and all patents and patent applications referred to herein arehereby expressly incorporated by reference in their entireties herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to apparatus and methods fortreatment of obesity, and particularly morbid obesity. In particular,the present invention relates to devices and methods for attachment of agastrointestinal sleeve device within a patient's digestive tract fortreatment of obesity.

2. Description of the Related Art

Gastrointestinal sleeve devices for treatment of obesity have beendescribed in the prior applications listed above, as have variousdevices and methods for attachment of a gastrointestinal sleeve devicewithin a patient's digestive tract. The present invention is the resultof continued investigation into devices and methods for attachment of agastrointestinal sleeve device within a patient's digestive tract.

SUMMARY OF THE INVENTION

There is provided in accordance with one aspect of the presentinvention, an attachment system for attaching a device to the mucosalside of a wall of the gastrointestinal tract. The wall comprises, amongother tissue layers, a muscularis layer and a serosal layer. The systemcomprises a gastrointestinal attachment cuff having a tubular body, aproximal end and a distal end. At least one attachment structure(sometimes referred to as a tissue anchor) is provided for transmuralattachment of the cuff to the mucosal side. The anchor comprises aconnecting element (sometimes referred to as a tension element) forextending through the wall and at least one transverse retention surfacefor positioning in contact with the serosal tissue. The cuff may be aunitary annular component or assembly, or may comprise two or three ormore components spaced circumferentially apart about a longitudinalaxis.

The tension element may comprise a suture. The tension element comprisesa proximal end for extending through the mucosal layer and a distal endfor carrying the transverse retention surface. The transverse retentionsurface comprises a proximal surface of a serosal anchor. The serosalanchor may comprise a T-tag, a disk, or an inflatable structure. Theserosal anchor is transformable between a first, reduced profile fordistal transmural advancement through the wall, and a second, enlargedprofile for resisting proximal retraction through the wall.

The tension element has a length between the cuff and the transverseretention surface, and the length is generally at least about 2 mm andoften no more than about 20 mm. In some implementations of theinvention, the length is within the range from about 2 mm to about 10 mmand, depending on the patient, potentially within the range from about 3mm to about 6 mm. Preferably, the connecting element is at least as longas the uncompressed wall thickness of the tissue at the attachmentpoint.

The attachment system may additionally comprise a first engagementsurface carried by a first coupler on the attachment cuff for couplingto a second, complementary engagement surface carried by a secondcoupler on a gastric bypass tube. The first and second couplers may beconfigured for removable coupling or permanent coupling between thebypass tube and the cuff. The bypass tube may have a length of at leastabout 50 cm, at least about 75 cm and in certain embodiments at leastabout 100 cm. The system may comprise at least 6 tissue anchors, and, insome applications, at least 12 tissue anchors.

The cuff may be omitted and the proximal end of the bypass tube may beattached directly to the adjacent tissue. The use of a cuff may bepreferred, however, if removal or replacement of the bypass tube iscontemplated, or if it is desirable to separate the steps of tissueattachment and bypass tube placement.

There is provided in accordance with another aspect of the presentinvention, a method of attaching a device to the mucosal side of a wallof the gastrointestinal tract, the wall comprising a muscularis layerand a serosal layer. The method comprises the steps of providing atension element, having a retention element thereon. The retentionelement is advanced through the wall from the mucosal side and theretention element is placed such that it is spaced apart from themuscularis by serosal tissue. Changes are caused to the serosal tissuein between the retention element and the muscularis. The device isattached to the tension element, such that the device is positionedadjacent the mucosal surface. As used herein, mucosal surface is a termof directional orientation and refers to the tissue surface facing theinterior of the body lumen such as the lower esophagus or stomach, whichmay be covered by an endothelial layer.

The changes may be caused to the serosal tissue following the attachingstep. The changes may be caused to the serosal tissue prior to theattaching step. The changes may be caused to the serosal tissue inresponse to tension on the tension element, biasing the retentionelement against the serosal surface. Alternatively, the changes may becaused to the serosal tissue in response to the application of an activeagent. The active agent may comprise a growth factor, a sclerosingagent, or other agent or process for increasing the tissue density (e.g.initiating a fibrotic response) of the serosal tissue residing betweenthe retention element and the muscularis.

In accordance with a further aspect of the present invention, there isprovided a method of treating a patient. The method comprises the stepsof providing a gastrointestinal attachment cuff having a tubular body, aproximal end and a distal end. The gastrointestinal cuff is positionedin the patient's digestive tract adjacent a mucosal surface in thevicinity of the gastroesophageal junction, the mucosal surface separatedfrom a serosal surface by a wall thickness. The gastroesophageal cuff issecured adjacent the mucosal surface by advancing at least three tissueanchors through the mucosal surface, across the wall thickness andthrough the serosal surface to position a transverse retention surfaceof each tissue anchor in contact with the serosal surface. Preferably,the foregoing steps are accomplished endoscopically.

The securing step may comprise advancing at least 6 tissue anchorsthrough the mucosal surface, and, in certain applications, at least 12tissue anchors.

The tissue anchor comprises a tension element such as a suture forconnecting the transverse retention surface to the cuff. The transverseretention surface may be a surface on a T-tag, a disk, or otherretention structure. The length of the tension element may be at leastabout 75% of the wall thickness between the mucosal surface and theserosal surface. Preferably, the length of the tension element is atleast about 95% of the wall thickness, and, optimally, the length of thetension element is greater than the wall thickness. In one embodimentthe length of the tension element is at least about 120% of the wallthickness.

The method may additionally comprise the step of providing an elongateflexible gastric bypass tube having a proximal end and a distal end, andattaching the proximal end to the cuff. The proximal end of the bypasstube may be attached to the cuff endoscopically. The attaching theproximal end of the bypass tube to the cuff step may comprise removablyattaching the proximal end of the bypass tube to the cuff. The distalend of the bypass tube may be positioned in the patient's jejunum, or inthe patient's ileum.

Further features and advantages of the present invention will becomeapparent to those of skill in the art in view of the detaileddescription of preferred embodiments which follows, when consideredtogether with the attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a gastrointestinal sleeve device attached to an artificialstoma device implanted within a patient's stomach.

FIG. 1B shows a gastrointestinal sleeve device attached at the GEJ withan attachment cuff.

FIG. 2A shows a schematic illustration of the GEJ and the SCJ or Z-lineand the target tissue zone identified by the present inventors.

FIG. 2B shows a schematic illustration of a tissue anchor placedadjacent the serosa at the time of implantation.

FIG. 2C shows a schematic illustration as in FIG. 2B, at a postimplantation stage when the anchor has relocated into the serosa, and alayer of increased tissue density has formed on a proximal side of thetissue anchor.

FIG. 2D is a schematic illustration as in FIG. 2C, with the anchorrelocated proximally into the plane of the muscularis.

FIGS. 2E-2F show an attachment cuff attaching a gastrointestinal sleevedevice using T-tags secured with a button.

FIGS. 3A-3D illustrate examples of expanding T-tag fasteners.

FIGS. 4A-4B illustrate placement of fasteners.

FIG. 5 shows a fastener device being driven through a single tissuelayer, with the attachment means positioned adjacent a mucosal surfaceand the cone shaped spring positioned on the serosal surface.

FIG. 6 shows another embodiment of a fastener system comprising a hangerthat as shown, may also function to hold two layers of folded tissuetogether (a plication). This fastener has a toggle that pivots on ahinge so that is can be aligned with the post as it is passed throughtissue layers, and can then be pivoted to hold the tissue layerstogether.

FIG. 7 is an exploded view of a transmural tissue anchor and spacer.

FIG. 8 shows the tissue anchor of FIG. 7 in a deployed condition.

FIG. 9 shows the tissue anchor of FIG. 7 being removed.

FIGS. 10A-10D illustrate an alternate tissue anchor design.

FIGS. 11A-11D show wire fasteners useful for placing a transmural tissueanchor.

FIGS. 12A-12B show two views of a T-tag embodiment of a tissue anchor.

FIGS. 13 and 14 show a T-tag embodiment with a living hinge.

FIGS. 15A-15B, 16A-16B, 17A-17B, 18A-18B, 19A-19B illustrate variousT-tag embodiments.

FIG. 20 shows a high-strength polymer T-tag embodiment.

FIGS. 21A-21D show an X-tag anchor embodiment and deployment of such anembodiment.

FIGS. 22A-22B, 23A-23B, 24A-24B, 25A-25B, 26A-26B illustrate alternateT-tag embodiments.

FIGS. 27A-27B show a T-tag fastener with a spacer to avoid excessivepressure on the tissue.

FIGS. 28A-28D show deployment of another T-tag fastener with a spacer toavoid excessive pressure on the tissue.

FIGS. 29A-29C show an inflatable balloon cuff-link anchor.

FIGS. 30A-30K illustrate inflatable balloon anchor adaptations.

FIGS. 31A-31C illustrate a method for placing inflatable anchors. FIGS.31D-31H illustrate various sleeve embodiments.

FIGS. 32A-32C illustrate methods and apparatus for delivering inflatablesilicone and mechanical anchors.

FIG. 33 illustrates a mechanical cuff-link anchor assembly.

FIG. 34 illustrates a radially expandable anchor embodiment.

FIG. 35 illustrates a method and apparatus for placing T-tag fastenersat the gastroesophageal junction (GEJ).

FIG. 36 shows a device being parachuted into place along a plurality ofsuture tails.

FIGS. 37A- 37G illustrate a dual-headed T-tag fastener.

FIGS. 38-43 show the steps for deploying a dual-headed T-tag fastener.

FIG. 44A-44E shows a sewing method of delivering a T-tag.

FIGS. 45A-45C show variations of a rail-mounted delivery device fordeploying a T-tag fastener mounted on the exterior of a flexibleendoscope.

FIG. 46A-46B shows another embodiment of a delivery device for deployinga T-tag fastener mounted on the exterior of a flexible endoscope.

FIG. 47 is a detail drawing of a pusher for use with a T-tag fastenerdelivery device.

FIG. 48 shows a proximal end of a delivery device with a magazine forsequentially delivering multiple T-tag fasteners.

FIG. 49A shows a snap T-tag fastener.

FIG. 49B shows the snap T-tag fastener of FIG. 49A with the cap inplace.

FIGS. 50A-50D show a method of T-tag fastener delivery with the suturetail inside of the penetrating cannula.

FIGS. 51A-51D show a slotted penetrating cannula with a pusherconfigured to exclude the suture tail of the T-tag fastener from theslot.

FIGS. 52A-52B show a method of rotationally orienting a T member of afastener after insertion.

FIG. 53 shows another method of rotationally orienting a T member of afastener after insertion.

FIGS. 54A-54C show embodiments of a grasping device combined with anattachment device.

FIGS. 55A-55H show different possible configurations of T members.

FIGS. 56A-56B illustrate another means for removably attaching agastrointestinal sleeve device.

FIGS. 57A and 58A-58C show an example of vertically mounted isolatedsliding attachment members in a patient's stomach. FIG. 57B shows anexample of a vertically mounted isolated hook and loop attachmentstructure in a patient's stomach.

FIGS. 59-60 show a compliant fastener that can accommodate large gastricwall motions.

FIGS. 61A-61B, 62A-62B and 63A-63B show embodiments of a flexibleattachment device with a removable bypass tube.

FIG. 64 is a cutaway drawing showing the internal construction of anembodiment of a flexible attachment device.

FIG. 65 shows an attachment device for attaching a treatment device thatis larger in diameter than the attachment device.

FIG. 66 illustrates an attachment cuff with an external sleeveattachment interface.

FIG. 67 illustrates an attachment cuff with separation of the attachmentand sealing functions.

FIGS. 68-69 show examples of tissue prestrengthening in thegastrointestinal system.

FIGS. 70-71 show examples of tissue thickening in the gastrointestinalsystem.

FIGS. 72A-72C show the effect of tissue thickening on a fixed lengthsuture or fastener.

FIGS. 73A-73C show controlled suture lengthening to compensate fortissue thickening.

FIGS. 74A-74E illustrate an embodiment of a fastener with controlledsuture lengthening to compensate for tissue thickening.

FIGS. 75A-75B illustrate another embodiment of a fastener withcontrolled suture lengthening to compensate for tissue thickening.

FIGS. 76A-76B illustrate another embodiment of a fastener withcontrolled suture lengthening to compensate for tissue thickening.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

U.S. patent application, Ser. No. 10/698,148, previously incorporated byreference, describes gastrointestinal sleeve devices that can mimic aRoux-en-Y gastric bypass by effectively reducing stomach volume,bypassing a portion of the stomach and/or small intestines, reducingnutrient absorption in the stomach and/or small intestines anddepositing minimally or undigested food farther than normal into theintestines, thereby stimulating intestinal responses. Thegastrointestinal sleeve devices described therein are all adaptable foruse with the apparatus and methods of the present invention. FIGS. 1A-1Bshow representative examples of such gastrointestinal sleeve devices.

FIG. 1A shows a gastrointestinal sleeve device 200 attached to anartificial stoma device 202 implanted within a patient's stomach. Theartificial stoma device 202 can be implanted in the vicinity of thegastroesophageal junction, or at the outlet of a surgically createdgastric pouch to create a restriction that limits the volume of foodthat can be ingested at one time. The artificial stoma device 202 canhave a fixed diameter stoma opening 204 or it can have an adjustablestoma opening or it can be a “smart” stoma that adjusts the size of thestoma opening in response to various conditions. The artificial stomadevice 202 is preferably configured for peroral delivery and attachmentusing endoscopic techniques. Alternatively, the artificial stoma device202 can be implanted using laparoscopic or open surgical techniques. Thegastrointestinal sleeve device 200 is an elongated flexible tubularstructure that is attached to the artificial stoma device 202 such thatfood and liquids pass through the stoma opening 204 and enter theinternal lumen 208 of the sleeve device 200. The artificial stoma device202 and the gastrointestinal sleeve device 200 can be implantedsimultaneously, or the artificial stoma device 202 can be implanted byitself and then the gastrointestinal sleeve device 200 can be attachedto the artificial stoma device 202 in the same or a subsequentprocedure. The stomach may tend to shrink around the sleeve device overtime due to disuse, reducing the stomach volume and increasingperistaltic coupling between the stomach wall and the sleeve device.Optionally, a line of staples or other fasteners 206 may be used withany of the devices to create a gastroplasty to reduce the volume of thestomach.

In conjunction with the stoma and/or gastric sleeve, the volume of thestomach can be reduced by suturing, stapling using open, transesophagealor laparoscopic techniques. Alternatively or in addition, a gastricballoon or other volume displacement device may be used in conjunctionwith the gastric sleeve to provide a feeling of satiety. Theseadjunctive techniques may have the effect of further reducing nutrientintake (in the case of a stomach reduction and pouch formation upstreamof a stoma) and enhancing the effect of peristaltic motions of thestomach for moving food through the gastric sleeve intake (in the caseof a stomach reduction downstream of a stoma where there is a gastricsleeve).

FIG. 1B shows a gastrointestinal sleeve device 200 attached at the GEJwith an attachment cuff 214. Tissue anchors, described below, have beenomitted for simplicity. The cuff 214 may include a plurality ofpreformed apertures 215 for attachment of tissue anchors as is discussedbelow. The attachment cuff 214 and the gastrointestinal sleeve device200 can be implanted simultaneously, or the attachment cuff 214 can beimplanted by itself and then the gastrointestinal sleeve device 200 canbe attached to the attachment cuff 214 in the same or a subsequentprocedure. The attachment cuff 214 and/or gastrointestinal sleeve device200 may, in one embodiment and as shown in FIG. 1B, be provided withpreformed holes 206 for attachment of tension elements as describedherein. Optionally, the attachment cuff 214 can be allowed to heal for aperiod of time before attaching the gastrointestinal sleeve device 200.Additionally, the gastrointestinal sleeve device 200 can be laterremoved or replaced without removing the attachment cuff 214. In thisexample, the volume of food ingested is limited by the portion of thesleeve device 200 upstream of the pylorus 220 rather than by arestrictive stoma. Furthermore, attachment at the gastroesophagealjunction excludes all gastric secretions from the interior of thegastrointestinal sleeve device 200.

In each of these examples, the gastrointestinal sleeve device 200preferably has a length such that ingested food and liquids bypass mostof the stomach and at least a portion of the small intestine. Undigestedfood and liquids exit the distal end 210 of the sleeve device 200 intothe small intestine reducing caloric absorption and elicitingphysiological responses within the intestines. The gastrointestinalsleeve device 200 can have a constant diameter throughout its length orthe diameter may vary along the length. The gastrointestinal sleevedevice 200 can be impermeable along the entire length or some or all ofthe device may be porous or semipermeable. Preferably, the wall of thegastrointestinal sleeve device 200 is thin and flexible so thatperistalsis is coupled to the internal lumen 208 of the device. Agastric sleeve that extends beyond the pylorus 220, with or without anintestinal sleeve, can allow use of the pylorus as a natural stoma byconfiguring the sleeve to close by the pylorus and then open to allowpassage of food when the muscles of the pylorus relax. The section ofthe sleeve device 200 that passes through the pylorus 220 willpreferably have enough wall flexibility or compliance to allow normalopening and closing of the pylorus to release and retain stomachcontents and to allow drainage of stomach secretions around the outsideof the sleeve. This can optionally be accomplished by the inclusion ofpleats, channels or other structures to facilitate the collapse andsealing of the sleeve as well as passage of gastric secretions along theoutside of the sleeve as shown in FIG. 1B.

Structures, features and methods illustrated in FIGS. 1A-1B can becombined or interchanged based upon clinical requirements. Similarly,dimensions, materials and other specifications described in U.S. patentapplication Ser. No. 10/698,148 can be adjusted based upon the clinicalsituation. For example, the gastrointestinal sleeve 200 is preferablyapproximately 60-180 cm in length whereby partially digested orundigested nutrients exit from the sleeve into the jejunum where theycan elicit a hormonal, neural and/or osmotic reaction in the jejunumand/or ileum. Increasing the length of the sleeve can reduce theabsorption of nutrients in a manner similar to that of a Roux-en-Y orbypass device, as will be understood by those skilled in the art. Thesleeve may extend sufficiently far into the intestine, such as past theligament of Treitz, so that it is retained in the intestine and notpushed back into the stomach. Lengths of at least about 50 cm, at leastabout 75 cm, at least about 100 cm and at least about 120 cm arecontemplated, although different lengths may be appropriate dependingupon the requirements of a particular patient. Thus, lengths of nogreater than about 5 cm or no greater than about 10 cm or no greaterthan about 20 cm may be desirable for certain patients.

The releasable attachment of the sleeve to the cuff as disclosed hereinfacilitates removal and replacement of the sleeve. Thus, the response ofa particular patient to a first sleeve having a first length can beobserved. If more or less intestinal absorption is desired, the firstsleeve can be endoscopically removed such as by cutting the tensionelements discussed below, and replaced by a second sleeve having asecond shorter or longer length. Therapy is thus adjustable, which maybe desirable if either the initial sleeve length was suboptimal or if itbecomes suboptional due to post implantation changes such as stomachremodeling or behavioral changes.

Optionally, the sleeve can include coatings on its interior and/orexterior to enhance the surface properties of the sleeve in clinicallyrelevant manners. Coating examples include: 1) parylene coatings toincrease the chemical resistance of a sleeve material, 2) coating withan antimicrobial agent to resist infection and/or 3) coating with ananti-inflammatory agent to reduce tissue inflammatory response, asdescribed herein. Similarly, the interior and exterior of the sleeve canoptionally be coated with a low friction material (e.g. a hydrogel) toreduce friction of food passage (interior) and reduce gastric irritation(exterior). One example of such a low friction material is a lubriciouscoating such as the PHOTOLINK LUBRICIOUS COATING manufactured bySurmodics Inc. and disclosed on pg. 5, paragraph 58, in U.S. utilitypatent publication 2005-0049718, the disclosure of which is hereinincorporated in its entirety by reference.

U.S. patent application Ser. No. 10/698,148 describes the use ofbiodegradable or bioresorbable materials for construction of agastrointestinal sleeve device to obviate the need for removal of thesleeve device at the end of the treatment period. The entiregastrointestinal sleeve device or a portion of it may be made ofbiodegradable material. The gastrointestinal sleeve device may be madeof biodegradable materials with different rates of degradation orresorption. The gastrointestinal sleeve device may be configured with aseries of segments that biodegrade sequentially. For example, a firstportion on the distal end of the sleeve may degrade first, followed sometime later by a second intermediate portion and a third proximalportion. Next the attachment would degrade and, finally, the T-tags orother fasteners would degrade. Alternatively, the gastrointestinalsleeve device may be configured with a series of short segments ofnon-biodegradable material that are attached to one another withbiodegradable material. The biodegradable attachment portions may bemade of biodegradable materials with different rates of degradation orresorption so that they biodegrade sequentially. In either case, thebiodegradable material would allow a gradual change of therapy overtime, without having to revise or replace the implant. The patient couldget used to the gradual change in therapy more readily than a suddenchange and may be better able to avoid a rebound in weight gain. It mayalso allow for a safe mode of degradation and elimination. The devicewould degrade into pieces small enough that they could be eliminatedwithout any danger of bowel obstruction.

Alternatively, selected portions of the gastrointestinal sleeve devicemay be made of biodegradable material. For example, openings in thesleeve can be covered with biodegradable material that will graduallydegrade over time, eventually allowing food to mix with digestivesecretions. The biodegradable material would allow a gradual change oftherapy over time, without having to revise or replace the implant. Thegastrointestinal sleeve device with the openings in it could be left inplace for long-term maintenance of weight loss or it could eventually beremoved.

In some embodiments the rate of degradation of the biodegradablematerial forming the sleeve could be coordinated with the natural pH ofthe anatomical environment and/or to properties of the material formingthe sleeve, to achieve a predetermined sequential degradation of theimplant. In accordance with one degradation sequence, a distal(intestinal) portion of the sleeve dissolves before the proximal(gastric) portion. For example, the sleeve could be constructed of amaterial that degrades at a faster rate in a relatively basicenvironment than in a relatively acidic environment such that the distalportion of the sleeve in the intestine would dissolve before theproximal portion of the sleeve in the stomach. The pH of the sleeveenvironment could also be altered by an external source, for example byingestion of a substance that would change the pH of the stomach and/orintestine and thus hasten degradation of the gastric component.Alternatively, the distal and proximal portions of the sleeve could beconstructed of two different materials with the material comprising thedistal portion dissolving faster than the material comprising theproximal portion. Alternatively, the material forming the sleeve couldbe thinner at the distal portion than at the proximal portion such thatthe distal portion would dissolve in less time than the proximalportion. All or any combination of the above alternatives could be usedto set the time frames of degradation of the distal and/or proximalportions of the sleeve depending on the desired performance.

Biodegradable material suitable for construction of a gastrointestinalsleeve device is sold under the name Plastifilm by OsteoBiologics, Inc.,located in San Antonio, Tex. This biodegradable polymeric film materialis described in U.S. Pat. No. 6,514,286, which is hereby incorporated byreference. Additional information from the supplier about this materialis available at: http://www.obi.com/.

Another aspect of the present invention involves devices and methods fordelivery and deployment of a gastrointestinal sleeve device into apatient's gastrointestinal tract. One method to facilitate delivery ofthe device into and through the patient's small intestine is to place aguidewire and/or catheter into the intestine to the depth desired andthen push the gastrointestinal sleeve device over the guidewire.Successful techniques for placing a guidewire into the small intestineshave been described by G. Long, T. Mills and C. P. Swain in an articleentitled Techniques for advancing guide wires and devices in the lumenof the gastrointestinal tract. Another technique that could be adaptedfor placing a device such as a gastrointestinal sleeve device into thesmall intestine was described by H. Yamamoto and K. Sugano in an articleentitled A new method of enteroscopy—the double-balloon method, Can JGastroenterol. 2003 April; 17(4):273-4. These techniques can be used incombination with many of the delivery and deployment methods describedherein and in the prior application.

Methods of insertion and retrieval of a gastrointestinal sleeve deviceare also described in the parent application. In addition to the methodsdescribed therein, a GI sleeve can be inserted and/or retrieved using aflexible endoscope. A skilled GI endoscopist can “drive” a specialendoscope (an enteroscope) through the duodenum and deep into thejejunum. Because of its small size, a pediatric colonoscope can be usedto access an area further down the intestine. With proper interfacingstructure on a GI sleeve, the sleeve can piggyback on the endoscope asit is driven into the jejunum and then released with its distal end leftin the jejunum when the endoscope is retracted and removed from thebody. This can be accomplished perorally either before or afterattachment of the proximal end of the sleeve to tissue or to a cuff atthe GEJ or some other clinically desirable location.

Various structures can be used as an interface between the endoscope andthe distal end of the GI sleeve device. If the sleeve device has a soliddistal end or other graspable portion, such as a tab or loop near thedistal end, a standard or custom endoscopic snare or grasper can beextended through the endoscope working channel to grasp the sleevedevice. Alternatively, the distal end of the sleeve device can beconfigured with a socket or pocket to engage a flexible pusher, whichmay be configured as a rod, tube or guidewire. As another alternative,the sleeve device can be configured with a distal end that can be cutoff to release the device. The distal end of the sleeve device isgrasped with a snare or the like extended through the endoscope workingchannel. Once the sleeve device is delivered far enough distally in theGI tract, the distal end of the sleeve device is cut off to release thedevice.

In one embodiment, delivery of the sleeve device to an area sufficientlyfar down the intestine is facilitated by attaching a traction structure,such as a mercury ball, that increases the likelihood that the sleevewill be pulled down the intestine, to the distal end of the sleeve.During peristalsis the intestinal wall grabs hold of the tractionstructure and pulls it along with the distal end of the sleeve down theintestine.

Location of Attachment of the Sleeve Device

The present inventors believe that some areas of the esophageal orgastric wall exhibit physical properties more conducive to retainingattachment structures than other areas. For example, an attachment zone8030, shown in FIG. 2A, directly above the squamocolumnar junction (SCJ)8020, also known as the Z-line, ora serrata, and mucosal GEJ, may besuch an area. The SCJ marks the junction of the squamous mucosa of theesophagus and the columnar or glandular mucosa of the stomach. The SCJmay be located at or below the lower esophageal sphincter (LES).

The device may, in one preferred embodiment, be attached in anattachment zone 8030 no more than about 2 cm and preferably no more thanabout 1 cm above the SCJ 8020 and below the esophagus 8000 where thesquamous mucosa is thicker than the squamous mucosa of the esophagus8000 and where there exists a serosal outer surface not exhibited at theesophagus 8000. The thicker layer of squamous mucosa in the attachmentzone 8030 terminates distally at the endoscopically visible transitionto the glandular mucosa of the stomach 8010 which occurs at the SCJ8020. The device is also preferably attached at a location in theattachment zone 8030 so as to minimize the risk of reflux. The SCJ 8020can be located relative to other anatomical regions. It normally may befound at the gastroesophageal junction (GEJ). The GEJ is the region atwhich the tubular esophagus joins the saccular stomach. The GEJ can beconsidered the first part of the stomach 8010 or the cardia and islocated at the proximal margin of the longitudinal gastric mucosal foldsor in the distal 2 cm of the esophagus 8000 and proximal stomach 8010.Endoscopically, the location of the GEJ can be approximated byidentifying the proximal margin of the gastric folds.

Thus, a first aspect to the location of attachment of the devicesdisclosed herein relates to the position of the attachment structuresalong the axis of the hollow lumen or organ. As described above, theattachment location in the axial direction is preferably in the vicinityof the gastroesophageal junction, and particularly just above the SCJ.This attachment site can be located endoscopically by observing thecolor change which occurs at the SCJ, and retracting or positioning theattachment structures of the endoscope slightly above that line.

A second aspect to the location of the attachment structure relates tothe depth within the adjacent tissue wall (i.e., in a transversedirection to the longitudinal axis described above) within which thevarious anchors or retention structures disclosed herein reside.Applicants believe that the location in the transverse direction issubject to migration or other change post-implantation, as described inconnection with FIGS. 2B through 2D.

Referring to FIG. 2B, there is disclosed a highly simplified schematicview of a tissue wall such as the wall of a hollow organ or lumen in thebody, including the wall at the vicinity of the gastroesophagealjunction. The tissue wall comprises a serosa 10 and a muscularis 12.Additional tissue layers have been omitted for simplicity. In general,as is appreciated by those of skill in the art, the serosa 10 is on theoutside of or faces away from the stomach, and the muscularis is on theinside, or faces towards the interior of the stomach. The serosa 10 thusincludes a serosal surface 14 which faces away from the interior of thestomach, and the muscularis 12 includes a muscularis surface 16 whichfaces towards the interior of the stomach.

An attachment device or anchor 18 is illustrated in part in FIGS. 2Bthrough 2D. The attachment device 18 can take any of a variety of forms,described elsewhere herein. In general, the attachment device 18includes a retention element 20 having at least one retention surface 22thereon. The retention element 20 may be integrally formed with orattached to a tension element 24, which extends through the tissue walland is secured to the device implanted within the gastrointestinaltract. Although the attachment mechanisms disclosed herein will bedefined primarily in the context of an obesity device, which is attachedin the vicinity of the GEJ, those of skill in the art will appreciatethat the attachment system disclosed herein may be utilized in any of awide variety of other anatomical locations, such as in the bronchialtubes, urethra, ureters, fallopian tubes, throughout the GI tract, andothers which share a serosa or serosa like layer, such as in the kidney,bladder, and other organs, as would be recognized by those skilled inthe art.

Referring to FIG. 2B, the retention element 20 is illustrated with theretention surface 22 residing against the serosal surface 14. Retentionsurface 22 may comprise any of a variety of forms, such as a proximalsurface on a T-tag, proximal surface on a disc, or any other surfacewhich extends in a generally lateral direction with respect to alongitudinal axis of the tension element 24. The transverse retentionsurface 22 may be radially enlargeable or expandable from a first,reduced cross-sectional configuration to provide a low crossing profilesuch as for deployment through a deployment cannula, and a second,radially expanded or enlarged cross-sectional profile as illustrated inFIG. 2B, to provide a retention surface 22 which will engage orinterfere with tissue of the serosa 10 or muscularis 12 to resistproximal retraction of the attachment device 18 through the tissue.Transformation between the first configuration and second configurationcan be accomplished in any of a variety of ways as is discussed furtherherein, such as by pivoting the retention element 20 about theattachment point to tension element 24, by radial expansion, byinflation, or other technique.

Tension element 24 may comprise any of a variety of connectors orelements adapted to extend through the tissue wall, such as a suture, orother single stand or multi-strand filament or material. In someembodiments the tension element 24 is formed of a polymer such as PEEKor silicone. The tension element 24 may also, in some embodiments, haveelastic properties. In other embodiments the tension element 24 does nothave elastic properties. By use of the term tension element, no specificmechanism is suggested, and the element is not required to be undermechanical tension.

The attachment device, otherwise sometimes referred to herein as atissue anchor, T-tag or other label, it is illustrated in FIG. 2B in aschematic fashion as it may appear at the time of implantation. Since incertain implementations of the invention the length of the tensionelement 24 will exceed the uncompressed thickness of the adjacent tissuewall, the retention surface 22 may even be spaced slightly apart fromthe serosal surface 14 depending upon the transient motion orconfiguration of the stomach at any given time.

Without being limited to any particular structure or mechanism,Applicants believe that the presence of the attachment device may causeor accelerate the formation of a layer 26 of serosal tissue havingincreased tissue density relative to unaffected or normal serosaltissue. The layer of increased density 26 may result from a process inwhich the transverse retention surface 22 places pressure against theserosa 10, causing a localized necrosis due to the restriction ofcapillary blood flow. The necrosed tissue thereafter fibroses, as a partof a normal healing response. The layer of increased density 26 orfibrosis may also result from a foreign body reaction triggered by thepresence of the transverse retention surface 22. Applicants haveobserved a greater degree of fibrosis or denser tissue on the side ofthe T-tag facing the lumen of the stomach, for example on the retentionsurface 22.

In certain animal trials conducted by Applicants in which the animalswere sacrificed five weeks following implantation of the attachmentdevice 18, successful anchors appeared similar to the simplifiedschematic illustration of FIG. 2C. In this illustration, the location ofthe retention element 20 has changed relative to the serosa 10 andmuscularis 12, and the distal surface 28 of the retention element 20 hasbeen covered with an overgrowth of serosal tissue 30. A fibrotic layer26 is positioned in between the retention surface 22 and the muscularis12. Although illustrated only on the proximal side of the retentionelement 20 where the greatest degree of fibrosis has been found tooccur, the fibrotic response appears to some extent to surround and walloff the entire retention element 20.

It appears to the present inventors that formation of a sufficientfibrotic response on the proximal side of the retention surface 22decreases the likelihood that the attachment device 18 will relocate tothe inside of the stomach under normal agitation of the stomach,changesin the thickness of the stomach wall, and other conditions normallyoccurring in the stomach. A similar response is schematicallyillustrated in FIG. 2D, in which the layer 26 of high density serosaltissue remains on the proximal side of the retention element 20, howeverone or both of the layer 26 and retention element 20 have relocated tobelow the normal plane 28 separating the serosa 10 from the muscularis12 and will remain there.

It appears to the present inventors that if the device design and/orretention element 20 design are such that in normal use the retentionelement 20 relocates to a position in the muscularis 12 and past theserosa 10 before a sufficient fibrotic response, the retention element20 may relatively easily pass through the muscularis 12 and failure willresult. Thus, it may be desirable in certain implementation of theinvention to facilitate or accelerate the formation of the fibroticlayer 26. This may be accomplished in any of a variety of ways whichwill be appreciated by those of skill in the art in view of the presentdisclosure, such as by the introduction of an active agent which willtrigger a fibrotic response. Suitable active agents may include any of avariety of growth factors, and/or chemical sclerosing agents which arewell known for other medical applications. Active agents may be appliedas a coating to the retention surface 22 or retention element 20, or maybe impregnated into the material of retention element 20, such as topermit a timed release into adjacent tissue. Incorporation may beaccomplished by loading the active agent into tortuous pathways or poresexposed to the surface of the retention element 20, or by inclusion in abioabsorbable or bioerodable carrier attached to or positioned in thevicinity of the retention surface 22. Energy sources may also beutilized, such as to generate heat or otherwise stimulate formation of afibrotic response, as is discussed further below. Formation of thefibrotic layer 26 may also be facilitated by mechanical means, forexample, in one embodiment, by roughening the retention surface 22 withthe addition of fibrotic layer enhancement structures such as aplurality of bumps or etched lines.

FIG. 2E shows an implanted gastrointestinal sleeve device 200 attachedby an attachment cuff 214 with the use of T-tags 207. FIG. 2F is anenlarged view of the attachment cuff 214 attached with T-tags 207showing the tension elements 209 of the T-tags 207 embedded in thestomach wall.

T-Tag Attachment Embodiments

T-tag fasteners can be used to attach many of the structures describedherein. A T-tag is basically a retention element 20 in the form of across member or “T” that is attached to a tension element 24 in the formof an elongated member or tail at or near the mid-point of the T. A“stem” may be a structure at the joining point of the T and tail. Fromthe perspective of a peroral attachment technique, in which theattachment devices are preferably advanced through muscularis 12 in thedirection of the serosa 10, the stem or tension element will be referredto herein as relatively proximal to the cross member on the T-tag. TheT-tag is a member of a more general family of tissue anchors, in which aproximally facing surface 22 (such as the proximal surface of the crossmember) is adapted to be bent, folded, or otherwise reduced in crossingprofile to a first configuration in which it can be advanced distallythrough a relatively small tissue opening, to a second configuration inwhich it presents a proximal serosal surface contacting area forresisting proximal retraction through the access pathway. Thus, althoughdescribed primarily in the context of a T-tag and variations thereof,the present invention relates more broadly to tissue anchors of the typefor presenting a retention surface which may have any of a wide varietyof configurations. Some are described in additional detail below. Thestem may also be referred to herein as a tension member, and maycomprise a suture, or other single strand or multi-strand element fordrawing the tissue anchor against the serosal tissue and/or connectingthe tissue anchor to the implantable cuff or other endolumenal implant.

T-tag fasteners are generally configured to flex or pivot at thejuncture of the T and tail to allow delivery along the axis of the Tthrough a minimal puncture diameter. T-tag fasteners can be configuredwith an extended tail that may extend out the mouth and optionally beused to parachute devices for attachment into position in vivo. OtherT-tag configurations can include, crimp, snap, screw or other means ofsecuring the T-tag tail when appropriate. One embodiment of a T-tagfastener could include a dual tail. Such a dual tail could be combinedwith extended tails that could then be tied out side the body with theensuing knots then tightened within the body. Such a dual tail could beconstructed of one of a number of non-biodegradable suture materialsknown in the art including polypropylene, nylon, braided Dacron or silk.In some clinical situations biodegradable tails could be indicated andcould be constructed using materials described herein. In a preferredembodiment the tails could be constructed of a monofilament material.

In certain implementations of the present invention, it may be desirableto increase the effective surface area of the retention surface 22. Thismay be accomplished using any of a variety of disc or button shapedattachment devices 18 disclosed herein, or by introducing a buttressingcomponent or element in the nature of a washer or other structure forenlarging the effective surface area. This buttressing structure maysometimes be referred to herein as a pledget. The buttressing materialis generally configured perpendicular to the axis of the attachmentmeans (e.g. suture, rivet or staple) and therefore best distributesforces along the axis of the attachment means. When a device is attachedto the intragastric wall such forces can be directed inward from thegastric wall. Therefore, if the buttress is attached to the intragastricwall, the buttress may not be along the axis best suited to resist theapplied force.

An alternate method of delivering these buttresses such as Fastener(T-tag) buttress (T-pledget) would be using a T-fastener (T-tag) wherethe “T” portion was constructed of a material with properties that wouldbe useful as a buttressing material. This would be a T-tag buttress or aT-tag pledget. Some embodiments of T-tag pledgets, 920, are shown inFIGS. 3A-3D. These T-tags could be delivered through a hollow needletype delivery system (e.g. T-ANCHOR INTRODUCER GUN (Moss, Moss Tubes))that has been redesigned/modified so it can be passed through theworking channel of an endoscope. One advantage of the use of T-pledgetsis that a T-tag can be designed with an elongated tail that can extentout through the mouth and be used to parachute structures into placein-vivo. T-pledget tails could include preloaded needles. Needles couldbe curved or straight.

In a preferred embodiment the cuff would be attached as the T-tags areplaced such that the sutures of the T-tags could be knotted outside ofthe body and the knots could be pushed down the working channel oroutside of the working channel of the scope until positioned to retainthe cuff. The suture tails could subsequently be removed. To facilitatemanagement of all the suture tails, two T-tags could first be placed tosecure the cuff followed by placement of the rest of the T-tags. In apreferred embodiment the T-tag tension elements, such as tails, sutures,or other structures as described herein, would terminate in the stomach,such as by tied knots, sliding buttons, or preexisting terminated ends,such that they would not need to be brought outside of the body.

In one embodiment deployment of the sleeve device and/or T-tags isachieved with the use of a remote controlled robotic endoscope.Generally, a remote controlled robotic endoscope comprises a userinterface, a control device, and an operating unit. Commands can beinputted by an operator into the user interface to activate the controldevice which in turn guides the operating unit in three dimensions. Theoperating unit, in one embodiment, can be a fastener deployment headcarried by a catheter which is positionable within the gastrointestinaltract and capable of attaching various fastener structures such assutures and T-tags in response to commands received by the userinterface. Monitors that display physical data and images of the anatomyto aid in navigation of the operating unit may also be used with aremote controlled robotic endoscope. Such an endoscope could scale theoperator's movements such that large movements of the operator wouldtranslate into the smaller movements that may be required to maneuverthe endoscope within the gastrointestinal tract. One embodiment of aremote controlled robotic endoscope is described in “RadiocontrolledMovement of a Robot Endoscope in the Human Gastrointestinal Tract,” byP. Swain, T. Mills, B. Kelleher, L. Schmitz, S. Mosse, P. Burke, K.Ikeda, and A. Fritscher-Ravens.

T-pledgets can be structured using a variety of means. A portion ofstandard Teflon pledget material can have a suture tied or otherwiseattached, at or near its mid point. This can be structured or otherwiseprepared for delivery by means such as rolling and/or compressing tofacilitate passage through tissue with a minimum disruption of thetissue layer. Ideally the T-pledget would have a minimum diameter whenpassing through tissue. Depending upon the clinical situation varyingdeployed diameters/areas could be preferred. A hollow needle or otherhollow tube can be used to facilitate passage through tissue. Structureand/or material selection to enhance axial rigidity along the axis ofdelivery will be beneficial in some clinical situations. A piercingpoint on the leading edge of the “T” may be useful with some deliverymechanisms.

Many of the features described herein can be achieved with constructionusing a single piece of Polypropylene, Nylon, PEEK, silicone, or otherpolymeric material well known in the art for use in constructionsutures, which forms the “T” and tail as a single unit. Alternately twodifferent materials can be combined, for example by insert molding, toachieve different properties of the “T” and tail. In another embodimentthis could be combined with a “T” portion that is coated with a materialselected for specific clinical properties such as encouraging ordiscouraging either in-growth or adhesion. The “T” portion may also besurrounded by another material such as Teflon pledget material or Dacrongraft material. “T” diameter will vary according to the material usedfor example ranging from 0.5 mm to 3.0 mm in diameter for nylon orpolypropylene with the typical “T” having a diameter of 1-2 mm. A tailcould be the dimension of a standard suture and could generally varyfrom 5-0 to 0 (USP standard classification) though smaller or largersizes may be appropriate in certain clinical situations.

In one configuration that could have advantages in certain clinicalsituations the “T” and/or tail portions of the T-pledget could beconstructed in part or wholly of a biodegradable material as describedherein. In one such configuration the “T” portion would be constructedof a flexible buttress material that is not biodegradable. In someembodiments this could have a tubular configuration. This would includea core of a more rigid material that is biodegradable. The tail in thissituation could be optionally biodegradable. This combination T-pledgetcan have advantages in that its “T” portion will 1) have increasedrigidity for insertion; 2) maintain its rigidity during the time periodwhile the tissue goes through its healing period and ideally until itregains its strength; and 3) become softer and more flexible to minimizethe potential for erosion over the length of time the pledget is inposition. Various buttress materials, both biodegradable and not, aredescribed herein.

In an alternative embodiment a porous buttress material could beimpregnated with a biodegradable material to achieve a similar result.Similarly a biodegradable material could coat a buttress material. Therigidity of both the permanent buttress material and the biodegradablematerial may be selected and modified to suit specific clinicalsituations. In some situations the biodegradable material may be of alesser rigidity compared to the buttress material. Embodiments thatinclude a biodegradable tail portion could have an advantage in certainclinical situations, as this would eliminate the tail as a focus for aleak after it has degraded. Bioresorbable materials such aspolyglecaprone (Monocryl, Ethicon), polyglactin (Vicryl, Ethicon) orother as well know in the art can be appropriate for use in theseapplications.

Bio-stable, solvent dissolvable pledget material—In other situations thepledget material could be made from a material that is stable in thebody but could dissolve in the presence of a biocompatible solvent, or abiocompatible solution including a chemical or catalyst that willinitiate the pledget's dissolution. This would allow simplified removalof the pledget material via lavage of the peritoneum if the stomachattachment means were to be released through an endoscopic procedure orwere otherwise desirable based upon the clinical circumstances.

Referring to FIGS. 3A-3D, Retention elements 920 are designed forexpandability. A T-tag or T-fastener can be used to provide knot freemeans to retain a suture against pull through of an associated anatomicstructure. A further advantage of a T-tag is that the forces applied tothe suture tail of the “T” are distributed over a larger area than asingle stitch. This is accomplished by using a “T” dimensioned with awidth wider than the diameter of the suture and a length longer than atypical bite or stitch. A disadvantage of a T-tag is that insertion of aT-tag through tissue potentially requires a hole many times, for example5-15 times, the diameter of the suture tail.

To deliver an improved buttressing capability in a T-tag fastener orT-pledget with a minimum delivery hole it is beneficial to use a “T” orpledget designed to expand after delivery. This can be beneficial inmany clinical situations. In addition to rolling or compressing,alternate structures can include materials that expand when exposed towater such as hydrogels. FIGS. 3C and 3D show how a T-pledget 920 orT-tag 918 of woven cylindrical meshes that may be compressed orelongated to achieve a reduced diameter and expanded or shortened tobecome wider. Compared to a rectangular sheet, alternate configurationsof a rolled and unrolled sheet can achieve a T-pledget 920 or T-tag 918with increased projected width relative to its rolled diameter throughthe use of matching cutouts, as shown in FIGS. 3A and 3B. Though not asefficient in diameter-to-projected width ratio, is some cases it may beclinically desirable to have a “T” that is in a circular shape.

To resist bending perpendicular to the axis of the suture, it may bebeneficial to use metals, for example Ti, SS or NiTi. In some clinicalsituations, encapsulating or coating the metal with a fluoropolymer orother coatings as described herein may also be beneficial.

T-tag with inflammatory reaction or other additives—The pledget materialcould be optionally coated or impregnated with materials and/ormedicaments as described herein. For example the pledget can be coatedwith a material that would enhance inflammation and scar formation.Alternatively, a coating or medicament that would either encourage ordiscourage in-growth can be applied.

In some clinical situations it may be beneficial to use both these typesof coatings. For example, though inflammation can lead to scarringfibrosis and ultimately strengthen tissue, the inflammatory processinitially results in tissue weakening that can include tissueliquefaction. Therefore, it can be desirable that a fastener thatinduces an inflammatory response for long term strength also includemeans to support the tissue during the weakened stage.

Inflammatory reaction materials would be limited to a portion of theT-tag or T-pledget as the inflammatory response weakens tissue beforethe scarring fibrosis occurs. Therefore, for example, having the area atthe center of the T or pledget with this inflammatory material and theends of the “T” without this material could have an optimized balance ofshort term and long term strength.

Drug-eluting coatings may be used to encourage or discourage tissueingrowth into the fasteners or other device attachment mechanismsdescribed herein. A low inflammatory response is generally desirable forencouraging tissue ingrowth. Anti-inflammatory drugs that may be usedinclude steroidal anti-inflammatory drugs, e.g. prednisone, andnonsteroidal anti-inflammatory drugs (NSAID), e.g. chromalin.Conversely, drugs that may be used to control or reduce tissue ingrowthinclude Taxol (paclitaxel) (Bristol-Myers Squibb) and Sirolimus(rapamycin) (Wyeth-Ayerst Laboratories).

Embodiments designed for improved erosion resistance—The purpose of the“T” or other retention element is to distribute and resist the forcesthat could act to pull it through tissue, in this case the gastric wall.To better achieve this result the “T” should resist excessive bending.Though a T-fastener is generally held parallel to the surface of theextragastric wall, at the ends of the “T” the gastric wall extendsoutward from the plane of the surface and the axis of the “T”. In thiscase, the gastric wall could be at a 90-degree angle, or greater, to theends of the “T”. To reduce the potential for erosion at the end of the“T” in some clinical situations it could be beneficial for the ends ofthe “T” to have increased flexibility which will result in a reductionof the angle between the gastric wall and the ends of the “T”. Thiswould reduce the forces between the “T” and the gastric wall andtherefore reduce the potential for erosion at the ends. Structures thatcould accomplish this could include tapered thickness or cross sectionto reduce the bending moment. Alternatively or in addition, changes inmaterial properties such as hardness, bending modulus and/or elongationcan accomplish the same result. For example the “T” near the stem couldbe of a material of a durometer such as Shore 65D or higher and thematerial may change as one moves out along the arms of the “T”transitioning through 55D/100 A to 90 A durometer or lower. Rounding,smoothing and structures that otherwise distribute forces over a largerarea will also serve to reduce erosion at the ends of the “T”. Acircular shaped “T” may be particularly desirable to reduce erosion.

FIGS. 4A-4B illustrate a method of placing T-tag fasteners 918 throughthe gastric wall that prevents accidental damage to other structures.One method of accomplishing this end could involve the use of anendoscope 920 with two (2) working channels. One channel could be usedto deliver a grasping means 921 that would grasp the gastric wall tostabilize the wall and optionally invaginate it to displace the areagrasped away from adjoining structures (e.g. spleen and aorta). Thesecond working channel can then be used to deliver a T-tag fastener 918through, for example, a hollow needle type delivery system 922 (e.g.T-ANCHOR INTRODUCER GUN (Moss Tubes)) that has been redesigned so it canbe passed through the working channel of an endoscope and then rotate 90degrees into position (as illustrated in FIGS. 5B and 5C). Laparoscopicor other extragastric means could also be applied to the end ofpreventing damage to adjoining structures. The grasping means 921 may beomitted from the procedure if desired.

For each subsequent T-tag fastener 918, the previously placedfastener(s) may be used to stabilize the gastric wall. The fasteners maybe used to assist in forming of a plication or in retracting andpositioning the gastric wall for fastening another component, such as astoma, sleeve or attachment ring. Similarly, other gripping means, suchas vacuum, transmural hooks and the like, may be used to facilitateplacement of retention elements 20 for fastening another component (e.g.cuff or bypass tube) of the system.

FIG. 5 shows the attachment or fastener device 651 being driven througha single tissue layer, with the attachment means 654 on the end of thepost 653 positioned within the passageway, and the cone shaped springpositioned 652 on the serosal side. The embodiment shown in FIG. 5 ispreferably configured so that its installation does not narrow thepassageway of the organ. Delivery of fastener embodiments communicatingwith the exterior of a hollow organ as shown in FIG. 5 may incorporatemeans to control capture of other structures. Though it may beclinically desirable to capture other structures as in the case ofcapturing the diaphragm by fasteners placed in the cardia of the stomachit is more likely that this would be undesirable. Fastening means couldincorporate shielding means and/or means to invaginate the organ wall asthe fastener is advanced through the organ wall.

FIG. 6 shows another embodiment of a fastener 660 comprising a hanger661 that also functions to hold two layers of folded tissue together.This fastener has a toggle 662 that pivots on a hinge 663 so that is canbe aligned with the post 664 as it is passed through tissue layers, andcan then be pivoted to hold the tissue layers together.

The toggle 662 helps to distribute forces that hold the fastener 660 inplace over the length of the toggle 662, and also prevents the fastener660 from being pulled through the hole. Alternative to the toggle 662, asimilar functioning apparatus such as a disc or a multi-arm umbrellacould also be used to distribute forces on the adjacent tissues whilepreventing the fastener 660 from passing through the hole. This fastenerfunctions similarly to the T-tag fasteners described herein. Some of theattachment structures described herein such as that of FIG. 6 areillustrated in connection with tissue plications; however, theseattachment structures may also be used transmurally, i.e., through onetissue layer.

FIG. 7 is an exploded view of a rivet-like surgical fastener 780. Thesurgical fastener 780 has two components, a spacer or rivet tube 782 anda rivet cap wire 788. The rivet tube 782 can be made of a biocompatiblepolymer or metal. The rivet tube 782 has a tapered distal end 786 aninternal lumen 784 sized to allow passage of the rivet cap wire 788 in astraightened condition. In its deployed condition, the rivet cap wire788 has a straight piercing section 796 on its distal end, followed bythe distal button 792, which is a section of the wire formed into acircle or spiral. Next, is a straight central section 790 that connectsthe distal button 792 to the proximal button 794, which is anothersection of the wire formed into a circle or spiral. In certainembodiments, the rivet cap wire 788 is made of a highly resilientmaterial, for example a superelastic NiTi alloy, which can be preformedinto this geometry by cold working and/or heat treatment, and which willreturn to this geometry after being straightened out for insertionthrough the internal lumen 784 of the rivet tube 782. Rivet tube 782 canbe constructed of a relatively bioinert material such as 304 or 316 SSor Ti unless the clinical situation suggests that a material thatencourages a scar forming healing response as discussed earlier isdesirable. Rivet tube 782 will typically have an outer diameter ofapproximately 0.25-1.5 mm with the inner diameter large enough toprovide for passage of a pre-formed NiTi wire of approximately 2×-6× thediameter of the wire. The tapered tip will preferably have a minimumclearance to allow free passage between its inner diameter and the outerdiameter of the NiTi wire. Wall thickness of tube 782 will typically beon the order of 0.002-0.005″.

FIG. 8 shows the surgical fastener 780 of FIG. 7 in a deployedcondition. The straight central section 790 of the rivet cap wire 788extends through the internal lumen 784 of the rivet tube 782, and thedistal button 792 and proximal button 794 are formed into asubstantially planar tissue-retaining geometry approximatelyperpendicular to the rivet tube 782 at the proximal and distal ends ofthe rivet tube 782. The straight piercing section 796 may be bent inwardslightly so that the distal button 792 protects it from inadvertentlypiercing any adjacent tissue structures when in the deployed condition.

The construction of the surgical fastener 780 allows it to be removed ifit is desired to reverse or revise the surgical procedure. FIG. 9 showsthe surgical fastener 780 of FIG. 7 being removed. A grasping tool orother rivet tube retaining tool 752 engages the proximal end of therivet tube 782 and a grasper 756 grasps the rivet cap wire 788 near itsproximal and withdraws it from the rivet tube 782 to release thefastened tissue.

The attachment fasteners described in FIGS. 7-9, although shown passingthrough two tissue layers of a plication, can be used to pass throughone tissue layer as well.

FIGS. 10A-10D shows an alternate rivet design 870 in which the rivettube 872 is provided with an attached or formed in place proximal rivetcap 874. The proximal rivet cap 874 can be formed as described earlieror formed as shown in FIG. 10A. FIG. 10B shows a multi fingered distalcap 876 that can be deployed by an axial advancement of the fingers, asshown in FIG. 10C. With a design that includes a proximal eye or othermeans of coupling, the fingers could also be retracted back into therivet body 872 if so desired. The fingers 876 of this rivet do notrequire the degree of superelasticity of the rivets described in FIGS.7-9 and could optionally be made from 304, 316 or other stainless steelsin addition to NiTi alloys, as well as other metals. FIG. 10D shows anexemplary apparatus 878 for deploying this type of rivet.

Stapling, suturing or other attachment of the implant is preferablyaccomplished transesophageally with the use of a flexible endoscope.Sutures may be placed into the muscularis, through the muscularis and/orfull thickness through the muscularis and serosa based upon the clinicalsituation. One method for accomplishing this involves the use of wirefasteners 130 that are formed with a “button” retention element end 132and a “twist tie” or other device attachment end 134, which are shown inFIGS. 11A-11D. In certain embodiments, the wire fasteners 130 are formedfrom a superelastic NiTi alloy so that the fasteners can be straightenedout and passed through a delivery cannula 136, as shown in FIG. 1A. Thedistal tip 138 of the wire can be sharpened so that it will penetratetissue. A portion of the distal end of the wire is formed so that itwill assume a circular or spirally curled “button” shape 132 after ithas passed through the tissue, as shown in FIG. 11B. The “button” shape132 attaches the fastener to the stomach wall and prevents it from beingpulled out through the tissue. The curl of the “button” 132 can beshaped so that it protects the sharpened distal tip 138 of the wire andprevents it from damaging the stomach wall or surrounding tissues afterthe fastener is deployed. There is an approximately 90 degree bend 140in the wire just proximal to the “button” portion 132. A portion of theproximal end of the wire is formed to create the “twist tie” 134, whichreforms when the wire fastener 130 is pushed out of the delivery cannula136, as shown in FIG. 11C. The “twist tie” 134 can be a helical curl orother shape that will entangle and interlock with a mating fastener whenthe two are approximated to one another, as shown in FIG. 11D.Alternately, the proximal end 134 of the wire fastener 130 can form aloop for attachment of standard suture materials.

The delivery cannula 136, which may be configured with a torquable shaftwith a fixed or variable curve 144 at the distal end, is used to deliverthe wire fasteners 130 to the desired location. The distal end of thedelivery cannula 136 is advanced until it contacts the stomach wall,then a pusher wire or the like is used to advance the wire fastener 130through the delivery cannula 136, as shown in FIG. 11A. As the wirefastener 130 exits the delivery cannula 136, the sharpened distal tip138 penetrates the stomach wall. The “button” portion 132 of the wireassumes its curved configuration distal to the stomach wall as thefastener 130 is advanced farther out of the delivery cannula 136, asshown in FIG. 11B. These steps are repeated to place a second wirefastener 130 in the opposite wall of the stomach. Then, the two deliverycannulas 136 are withdrawn while continuing to advance the wires out ofthe delivery cannulas to allow the “twist tie” portions to assume theirhelical curled shape proximal to the stomach wall and the two fastenersare approximated to one another so that the two “twist tie” portionsintertwist with one another as they exit the delivery cannulas to attachthe two walls of the stomach together, as shown in FIG. 11D.Alternatively, the wire fasteners 130 can employ a loop, rather than a“twist tie” to enable approximation using a secondary means such assutures. A line of fasteners 130 can be thus deployed to create agastroplasty pouch or band, or used to attach an attachment cuff orbypass tube to the stomach wall.

In an alternate embodiment, the wire fasteners may be configured to havea “button” portion 132 on both ends of the wire. These fasteners can bedeployed laparoscopically to penetrate both walls of the stomach with a“button” 132 placed on each side of the stomach to attach the wallstogether. Such fasteners can be combined with buttressing reinforcementssuch as pledgets made from Teflon, bovine or porcine tissue or otherknow materials. “T-tag” type fasteners could be applied to this use andtype of application.

FIGS. 12A-12B illustrate a T-tag fastener 1000 with a tubular standoffstem 1004 that is recessed inside of the T-member 1008 during insertionof the fastener. The T-member 1008 of the fastener can be straight,curved or another geometry, such as those described herein. Two strandsof suture thread 1012 are attached at approximately the center of theT-member 1000 and pass through the lumen of the tubular standoff 1004.The tubular standoff 1004 has a length corresponding approximately equalto or greater than the thickness of the tissue at the intendedattachment point. There is a groove or recess 1016 found in the T-member1008 of the fastener adjacent to where the suture threads 1012 areattached. The recess 1016 in the T member 1008 is sized to receive thetubular standoff 1004 when the T-tag fastener 1000 is in the undeployedposition for insertion of the fastener, as shown in FIG. 12A. FIG. 12Bshows a side view of the T-tag fastener 1000 in the deployed positionafter insertion through the tissue. The suture threads 1012 can be usedto attach a gastrointestinal sleeve device, an attachment cuff or otherimplantable device to the tissue and the tubular standoff 1004 preventsthe application of excess pressure that might lead to tissue necrosisand erosion at the attachment point.

One of the difficulties encountered with the use of fine filaments, suchas suture threads, for attachment of implants within thegastrointestinal system is that the filaments can cut through the tissuein the same way that a wire cheese cutter cuts through a block ofcheese. When the force on the filaments is perpendicular to the tissuewall, the force can be distributed over the tissue with a pledget and/orwith a T-tag fastener. However, when there is a large enough componentof force transverse to the tissue wall, the filaments can cut sidewaysthrough the tissue. The use of a stem, for example the tubular standoffas described above can distribute the force sufficiently to avoid thischeese cutter effect.

In a preferred embodiment the attachment structure, for example anon-plicating transmural attachment structure, would maintain thenatural anatomical shape of the stomach and move with the stomach ratherthan constrain its movements. An attachment structure that does notinterfere with the natural movements and shape of the stomach may reducethe cheese cutter effect and/or other failure modes that may increasethe risk of relocation of the T-tags into the stomach.

FIG. 13 illustrates a T-tag fastener 1100 with a stem 1104 attached tothe T-member 1108 to reduce the cheese cutter effect. In the exampleshown, the T-member 1108 of the fastener is curved to distribute theforces that are perpendicular to the tissue wall 1116. The stem 1104extends approximately perpendicular the T-member 1108 and has sufficientthickness to distribute the forces transverse to the tissue wall 1116 toavoid the cheese cutter effect. One or more suture threads 1112 areattached to the end of stem 1104 for attachment of an implanted device.Preferably, the stem 1104 has a length corresponding approximately equalto or greater than the thickness of the tissue at the intendedattachment point to act as a standoff to prevent excess pressure on thetissue at the attachment point.

FIG. 14 illustrates a T-tag fastener 1200 similar to the embodimentshown in FIG. 13 with the addition of a living hinge 1204 molded intothe fastener 1200 at the point where the stem 1208 attaches to theT-member 1212. This living hinge 1204 allows the stem 1208 to foldagainst the T-member 1212 for a low profile during insertion of thefastener 1200.

FIGS. 15A & 15B illustrate a tapered T-member 1300 for a T-tag fastenerwith a single eyelet 1304 for attachment of a suture or other filament.The contoured tissue-contacting surface 1308 of the tapered T-member1300 serves to distribute the attachment force for an implanted devicesmoothly across the tissue to eliminate any stress concentrations orpressure spots that could cause tissue necrosis and erosion. The taperedthickness of the T-member provides a gradual stiffness transition fromthe stiffer middle section 1312 to the more flexible outer edges 1316 ofthe T-member 1300, which allows the T member 1300 to flex and therebyfurther serves to minimize stress concentrations and higher pressurespots in the tissue at the attachment site.

FIGS. 16A & 16B illustrate a tapered T-member 1400 for a T-tag fastenersimilar to FIGS. 15A & 15B, but having a double eyelet 1404 forattachment of one or more sutures or other filaments.

FIGS. 17A & 17B illustrate a curved T-member 1500 for a T-tag fastener.The convex curved tissue-contacting surface 1504 of the curved T-member1500 serves to distribute the attachment force for an implanted devicesmoothly across the tissue to minimize any stress concentrations orhigher pressure spots that could cause tissue necrosis arid erosion. TheT member 1500 has a double eyelet 1508 for attachment of a suture orother filament. The T-member is preferably molded of a fairly rigid,high strength biocompatible polymer such as PEEK.

FIGS. 18A & 18B illustrate a curved T-member 1600 for a T-tag fastenerwith a pattern of alternating grooves and ridges 1604 for controlledflexibility. The convex curved tissue-contacting surface 1608 of theT-member 1600 serves to distribute the attachment force for an implanteddevice smoothly across the tissue to minimize any stress concentrationsor pressure spots that could cause tissue necrosis and erosion. Thepattern of alternating grooves and ridges 1604 formed on the oppositesurface of the T-member 1600 increases the flexibility of the T-member1600, which further serves to minimize stress concentrations and higherpressure spots in the tissue at the attachment site.

FIGS. 19A & 19B illustrate a curved T-member 1700 for a T-tag fastenerwith a pair of ridges 1704 for controlled flexibility. The convex curvedtissue-contacting surface 1708 of the T-member 1700 serves to distributethe attachment force for an implanted device smoothly across the tissueto eliminate any stress concentrations or pressure spots that couldcause tissue necrosis and erosion. The pair of ridges 1704 near thecenter of the T-member 1700 create a stiffer middle section 1712adjacent to the suture eyelet 1716 and a gradual stiffness transition tothe more flexible outer edges 1720 of the T-member 1700, which furtherserves to minimize stress concentrations and higher pressure spots inthe tissue at the attachment site.

FIG. 20 illustrates a tapered, curved T-member 1800 for a T-tag fastenerwith enlarged barbell shaped areas 1804 on the ends of the T-member1800. The convex curved tissue-contacting surface 1808 and the taperedarms 1812 of the T-member 1800 serve to distribute the attachment forcefor an implanted device smoothly across the tissue to minimize anystress concentrations or higher pressure spots that could cause tissuenecrosis and erosion, while the barbell shaped ends 1804 on the arms1812 of the T-member 1800 serve to minimize any stress concentration inthe tissue at the ends of the arms 1812 of the T-member 1800. Thebulbous barbell ends 1804 can be optionally combined with othermaterials or configurations described herein to provide flexibility tofurther reduce pressure concentrations. Optionally, the bulbous barbellends 1804 can be formed in a hollowed out or spoon-shaped configurationto increase flexibility and further reduce the stress on the tissue.Optionally, a stainless steel pin 1816 or the like may be inserted intothe molded polymer T-member 1800 to support the stress of the sutureattachment.

FIGS. 21A-21D illustrate an X-tag anchor embodiment 1900 and deploymentof an X-tag anchor embodiment 1900. FIG. 21A shows two T-members 1904placed one on top of the other in a cross configuration. FIG. 21B showstwo T-members 1904 in series within a delivery needle 1908. FIG. 21Dshows another view of the two T-members 1904 inside the needle 1908.FIG. 21C shows a cross-section of the X-tag anchor embodiment 1900illustrating the looped suture 1912 extending from the T-members 1904.

FIGS. 22A-22B illustrate an injection moldable tapered, curved T-member2100 for a T-tag fastener with an elliptical cross section as shown inFIG. 22B and rounded ends 2104 on the arms of the T-member 2100. Theupturned, canoe-shaped ends 2104 of the T-member 2100 are a variation onthe barbell-shaped ends 1804 shown in FIG. 20.

This and other alternate configurations can be used to optimize pressuredistribution and flexibility of the T-member. The T-member 2100 has adouble eyelet 2108 for attachment of a suture or other filament and agroove between the eyelets so that the bight in the suture will berecessed into the body of the T-member 2100. The T-member 2100 ispreferably molded of a fairly rigid, high strength biocompatible polymersuch as PEEK.

FIGS. 23A-23B illustrate a T-tag fastener 2200 with a hydrogel disc 2204that, can be placed between the deployed T-member 2208 and theextragastric surface. The disc 2204 could be delivered through the T-tagdelivery needle. It could unroll after passage through the needle. Thehydrogel disc 2204 acts as a buttress or pledget to distribute theforces transmitted between the T-member 2208 and the extragastricsurface and thereby it strengthens the attachment of the T-tag fastener2200. The hydrogel used in FIGS. 23A-23B can optionally be replaced withalternate materials described herein for example NiTi andfluoropolymers. A Hydrogel or other buttress or Teflon pledget for aT-tag could also deploy in some other manner. The disc configurationshown can be replaced with for example, braided or woven wires orfilaments that would expand/deploy after passage through the needle(FIGS. 24A-24B), a Malecot-style deployable tubular structure (FIGS.25A-25B) or other expandable or deployable configuration (e.g. FIGS.26A-26B). Although FIGS. 23A-23B, 24A-24B, 25A-25B, and 26A-26Billustrate T-tag fasteners, such as 2200 in FIGS. 23A-23B used withT-members 2208, uses of the T-tag fasteners without T-members and justwith the hydrogel disc 2204 of FIGS. 23A-23B or the woven filaments,Malecot-style tubular structure, or the expandable structure of FIGS.24A-24B, 25A-25B, and 26A-26B, respectively, are also contemplated.

It may be beneficial to limit the pressure applied to the tissue inorder to avoid tissue necrosis and erosion at the attachment points. AT-tag fastener can be configured with two suture threads going to themidpoint of the T-member, as shown for example in the anchor embodimentof FIGS. 12A-12B (or a single suture thread that passes through centerof the T-member). As an alternative to the stem described above, the twosuture threads are fused together or otherwise attached to one anotherover a selected distance from the T-member corresponding to thethickness of the tissue at the attachment point (for example about 10-15mm). Alternatively, a single suture thread could be connected to theT-member, which divides into two suture threads at a selected distancefrom the T-member. The T-member can be passed through the tissue wallusing an insertion cannula or the like and ends of the suture threadscan be used to tie the fastener to an anchor ring, gastrointestinalsleeve or other device. In this example a gap of 2-3 mm, or more,between the T-member on the serosal surface and the device on themucosal surface is assured. Thus, the suture threads can be tied verysecurely without creating excessive pressure on the tissue at theattachment points. This would simplify the procedure because the surgeonor endoscopist would not have to judge the knot tension to get thedevice snug against the mucosa without compressing the tissue.

Alternatively, the two suture threads can be tied together to create astop at a selected distance from the T-member. This is less preferredbecause the knot would likely have to be pushed through the tissue toallow the T-member to pivot to the deployed position, then pulled backthrough the tissue. This would require more force as there would be dragon the knot and the hole through the tissue would be a bit bigger. Otheralternatives to create a stop or common length of 2 sutures include useof a tightly fitting tube, for example heat shrink tubing, an adhesive(e.g. epoxy), a biodegradable adhesive (e.g. cyanoacrylate) or fusingthe 2 filaments over the desired length. Use of a slidable tube for thispurpose is described herein. Such tubes can be polymers (e.g. PE orTeflon) or metals (e.g. SS, NiTi or Ti) PB and Teflon tubes can beeither heat shrinkable or of fixed diameter depending upon the desiredperformance.

In the above examples where it has been suggested that a fixed distancebetween the T-member and the device it is being used to attach isdesirable it has been suggested that in some cases a distance greaterthan the thickness of the captured gastric wall may be clinicallyindicated. This is due to the ability/tendency/possibility that thegastric wall could react to the presence of a foreign body (theattachment structures) by thickening. In this event, in some cases, itcan be clinically preferable that the preset distance accommodate someor all of this increase in wall thickness.

The previous applications discussed mucosal ingrowth as a means tostabilize and seal an implant device, and to assure long-term attachmentin the stomach. Alternatively or in addition, the T-member of a T-tagfastener can be configured to encourage serosal ingrowth or fibrosis forstabilization at the serosal surface, as shown in FIG. 30K. Furthermore,the material passing through the tissue wall (e.g. suture, spacer tube)can be selected to form an optimal suture track by encouraging adesirable tissue reaction, for example fibrosis.). Similarly theT-member could be coated or treated to achieve these properties.Materials and coatings for these purposes have been described in theprior applications.

A dissolvable sheath (e.g. sugar, gelatin or other rapidly dissolvingmaterial) or stem can be used to control the position of a knot in thesuture as it can be used to prevent the knot being tied where the sheathis over the sutures. Furthermore, structures and methods that encouragetissue motion relative to the suture and the suture track can have animpact on tissue healing that can be beneficial or detrimental dependingupon the clinical situation.

The T-member of a T-tag fastener can be configured with a sharpeneddistal tip to pierce the tissue without the need for a separateinsertion cannula. The T-member can be detachably mounted on a pushershaft with a female socket on the proximal end of the T-member intowhich the pusher shaft is inserted. The sharpened distal tip of theT-member can be made from a material that dissolves or is bioabsorbableto provide a less traumatic long term implants. T-tags can be configuredwith other T-member or cross bar shapes, with a single suture, with orwithout needles on the ends of the sutures, and with a variety of crossmember materials. These materials can include polymers such asfluoroplymers, PU, PET, PEEK or silicone. They can also be made frommetals such as 55, NiTi or Ti or polymers reinforced with metals orother materials well known in the art (e.g. glass or aramid fibers.Furthermore, is some clinical situations materials that arebiodegradeable, as described in the prior applications, could bebeneficial.

FIGS. 27A-27B show a T-tag fastener 222 with a spacer 224 to avoidexcessive pressure on the tissue. The fastener 222 has a cross member or“T” 226 that is attached to a “stem” 228 at or near the mid-point of theT. For “blind” deployment of the fastener, the attachment point betweenthe T 226 and the stem 228 can be configured with a flexible hinge tofacilitate insertion through a needle or cannula. The stem 228 isconstructed with a spacer 224 that may be configured as a cylindricalshoulder on the stem as shown or, alternatively, a ring or bump on thestem of the fastener may also serve as a spacer. An attachment means 230is provided at the proximal end of the stem for attachment of a proximalcap 232. The attachment means 230 may include barbs, detents, crimpconnections, screw threads, or the like, with corresponding structuresor attachment means 234 on the proximal cap 232 for an easy and reliableattachment. Optionally, an elongated tail member 236 may be attached tothe proximal end of the stem 228 to aid in guiding the proximal cap 232into place on the attachment means 230 of the T-tag fastener 222. Thetail 236 may be configured as a pair of elongated sutures. The tail 236may be detachable or it may be made so that it can be cut off of thefastener after it has been placed.

Generally, the spacer 224 should be configured to limit the amount ofcompression applied to the gastric or esophageal wall upon deployment ofthe fastener 222. Where some compression is desired, the spacerdistance, that is the distance along the stem from the T 226 to theproximal cap 232 after deployment, should be slightly less than thetotal thickness of the tissue and other structures to be attached. Thespacer distance should take into account whether a single-walltransmural attachment or a double-wall plicated attachment is intended,as well as the thickness of any device structures that will be held bythe fastener. In cases where it is not necessary to apply compression,the spacer distance may be greater than the total thickness of thetissue and other structures to be attached.

In an alternate embodiment of the T-tag fastener 222 of FIGS. 27A-27B,rather than using a fixed-length spacer, the attachment means 230 may beconfigured to allow the proximal cap 232 to be attached at differentdistances from the T cross member 226. This would allow the operator toselect the correct spacer distance at the point of use and even to varythe spacer distance from one fastener to the next depending on tissueand device thickness at the attachment point. The correct spacerdistance may be determined by imaging techniques such as fluoroscopy orultrasound or it may be determined by using a force limiting ormeasuring mechanism in the fastener delivery and deployment device.

The T-tag fastener 222 of FIGS. 27A-27B can be deployed directly, forexample through a plication of the gastric wall, with a needle attachedto the proximal end of the tail member 236. Once the tail 236 has passedthrough the tissue, the proximal cap 232 is threaded onto the tail. Theproximal cap 232 is then attached to the stem 228 of the fastener byholding tension on the tail 236 and pushing the proximal cap 232 untilthe attachment means 234 of the proximal cap engages the attachmentmeans 230 on the stem 228. The tail 236 can then be removed from thefastener 222. Alternatively, the tail 236 can be used to attach anotherdevice to the T-tag fastener 222. The T-tag fastener 222 of FIGS.27A-27B can also be deployed blindly, for example for transmuralattachment through the gastric wall. The fastener 222 is insertedthrough a needle or cannula by pivoting the T 226 so that it isapproximately parallel to the stem 228. The needle or cannula is used topierce through the tissue to be attached; then the T 226 is pushed outof the cannula on the far side of the tissue using a pusher rod or tubethat extends through the cannula. The needle or cannula is withdrawn andthe T 226, which is now approximately perpendicular to the stem 228, issnugged up to the back surface of the tissue with a little tension onthe tail member 236. After the needle is withdrawn, the proximal cap 232is threaded onto the tail 236. The proximal cap 232 is then attached tothe stem 228 of the fastener by holding tension on the tail 236 andpushing the proximal cap 232 until the attachment means 234 of theproximal cap engages the attachment means 230 on the stem 228. The tail236 can then be removed from the fastener 222. The diameter of thespacer 224 and/or the stem 228 between the T 226 and the proximal cap232 can be minimized to reduce compression on the surrounding tissue or,alternatively, the spacer 224 and/or stem 228 can be configured to sealthe puncture through the tissue. FIG. 27B shows the T-tag fastener 222of FIG. 27A deployed through the gastric wall.

A gastrointestinal sleeve, a mounting cuff or ring or other device maybe attached directly to the gastric wall using several of the T-tagfasteners or other attachment devices as rivets. Alternatively, the stemand/or the proximal cap may be configured with a nubbin (FIG. 30H), aring (FIG. 30J), a hook, a loop (FIG. 30I), or the like, for attachinganother device to. As another alternative, the suture tails may be usedfor tying a device to the fasteners.

FIGS. 28A-28D show another T-tag fastener 240 with a spacer 242 to avoidexcessive pressure on the tissue. In this case the T-tag fastener 240 isspecially configured for low-profile blind deployment through a needleor cannula 248. The cross member or T 244 is attached at or near itsmid-point to a flexible stem 246, which in the example shown isconfigured as a pair of elongated sutures. A sliding spacer 242 orstandoff with a tubular configuration is threaded onto the sutures 246.The T-tag fastener 240 is prepared for insertion as shown in FIG. 28A byinserting it into the delivery cannula 248 with the T 244 at the distalend, followed by the spacer 242 in a tandem configuration. The sutures246 extend proximally through the delivery cannula 248. The tandemconfiguration provides a low profile for delivery through the cannula248. The fastener 240 may be loaded into the delivery cannula 248 ineither an antegrade or retrograde direction, depending on what is mostconvenient and economical.

The low profile provided by the tandem configuration of the T member 244and spacer 242 is desirable to minimize the size of the needle orcannula 248 needed to deliver the fastener 240. This is important notonly for minimizing the size of the tissue puncture, but also to reducethe amount of force needed to deliver and deploy the fastener 240through an endoscope. The delivery needle or cannula 248 will preferablybe 17 gauge or smaller, more preferably 19 gauge or smaller.

The T-tag fastener 240 is typically deployed as a blind fastener, forexample for transmural attachment through the gastric wall. The deliverycannula 248 is used to pierce through the tissue to be attached; thenthe T member 244 is pushed out of the cannula 248 on the far (serosal)side of the tissue using a pusher rod or tube that extends through thecannula 248. The needle or cannula 248 is withdrawn and the T member244, which is now approximately perpendicular to the sutures 246, issnugged up to the back surface of the tissue with a little tension onthe sutures 246, as shown in FIG. 28B. The sliding spacer 242 is pushedout of the delivery cannula 248 with the pusher rod or tube and sliddistally along the sutures until it contacts the T member 244, as shownin FIG. 28C. Several T-tag fasteners 240 can be inserted transmurally inthis manner around the gastroesophageal junction or elsewhere in thegastrointestinal system using a flexible gastroscope or the like. Thesutures 246 can then be used to attach a gastrointestinal sleeve, amounting ring or cuff or other device 238 to the mucosal surface of thegastric wall, as shown in FIG. 28D. The spacers 242 prevent excessivepressure on the gastric wall that could lead to undesirably highischemia and eventually to tissue necrosis.

Inflatable/Injectable Soft-Tissue Anchor Attachment Structures

Many suitable soft-tissue anchors include monolithic anchors,multi-component anchors, flip-style anchors, expanding anchors,rivet-style anchors, zip-tie style anchors, and sliding knot-styleanchors. Expanding balloon anchors may also be used for transmural,suture-less attachment that may be easily deployed through a smalldelivery needle and flexible endoscope and that have large surface areasthat interact with surfaces of soft-tissue, such as the outer surfacesof the esophageal or gastric wall, for increased attachment strength.

FIGS. 29A-29C show an inflatable attachment structure 2300 comprisingballoon anchors 2304 that interface with the outer surface of theesophageal or gastric wall. Such inflatable anchor attachment structures2300 have large surface areas, as shown in the balloon anchor 2304cross-section of FIG. 29C, that interact with the esophageal or gastricwall which gives them increased attachment strength. The large surfacearea, flexible nature, rounded edges, and curved profiles of thesestructures 2300 decrease stress concentrations which can lead topressure necrosis and ischemia and subsequent anchor detachment.Furthermore, these anchor structures 2300 are easy to deliver,particularly when only the inner surface of the esophageal or gastricwall is accessible. The small size of the anchors 2304 permits deliveryvia a small delivery needle through a flexible endoscope. Because theanchors 2304 do not require the use of sutures, the long-termembrittlement or fracture issues associated with sutures are avoided.The balloons 2304 may be inflated in-situ after delivery with, forexample silicone; the silicone subsequently cures resulting in an anchor2304 with very large surface area.

In some aspects of the invention the balloon anchor 2304 is preferablyan inflatable or injectable dual-ended balloon anchor for soft-tissuewhich when expanded has a barbell-style profile. When unexpanded thisanchor 2304 folds up and fits into a small delivery needle. The anchor2304 is formed of thin-wall silicone or polyurethane that is expandable.After the anchor 2304 is delivered to the desired soft-tissue locationvia a delivery needle and flexible endoscope it is expanded, preferablywith silicone, while in place. After the silicone cures the anchor 2304attains its barbell-style profile with very large surface areainterfacing with the outer surface of the soft-tissue. This largesurface area helps prevent pull-out of the anchor 2304. The ratio ofexpanded surface area to unexpanded size is unmatched by other systemsand provides maximum pullout strength with minimal tissue defects ortrauma. Furthermore, after the silicone has solidified, concerns aboutleakage, deflation, and toxicity are eliminated, and the result is areliable, long-term, implantable anchor 2304. The curvature, softcorners, and flexibility of the anchor balloons 2304 reduce stressconcentrations thereby preventing pressure necrosis and ischemia andresulting in long-term attachment strength. The barbell ends alsopreferably comprise a self-sealing membrane or self-sealing end caps2308 that seal upon removal of the inflation needle. In one embodiment,shown in FIG. 29B, the balloon anchors 2304 are connected by a hollowconnection tube 2312 in which there are holes 2316 for inflating theballoon anchors 2304. The anchor 2304 is a fixed length anchor toprevent over-tensioning on the soft-tissue which leads to pressurenecrosis. Because the anchor 2304 does not utilize any sutures,long-term embrittlement and fracture issues associated with sutures areavoided. Thus, this embodiment can be used to transmurally attach agastric sleeve device with the anchor 2304 passing in its unexpandedstate through the inner surface of the esophageal or gastric wall andbeing inflated at its final location at the outer surface of theesophageal or gastric wall.

Alternate anchor embodiments, as depicted in FIGS. 30A-30G, include:

-   -   one-ended inflatable anchors (FIG. 30A),    -   inflatable anchors with different end geometries including        discs, convex or concave bowls, mushroom-heads, and “L” or        “T”-profiles (FIGS. 30B-30G),    -   inflatable anchors filled with polyurethane, saline, air,        nitrogen, other low-to-high durometer silicones, PMMA        (polymethyl methacrylate), bone cement, or any other inert gas,        liquid, or semi-solid,    -   multiple-component anchors with two end balloons connected via a        connection tube or channel, the assembly being adhesively or        otherwise bonded together,    -   anchors comprised of osmotic membrane that expands and swells        when immersed in a fluid environment, such that it would not        have to be inflated by the user,    -   anchors with connection channels of adjustable lengths adjusted        based on tissue thickness measurements taken intra-operatively        using concentric shafts with threads, ratchets, detents and        other features.

All of the above anchor embodiments can be of various sizes. Mountingfeatures, as shown in FIGS. 30H-30J, can also be added to the anchors tofacilitate attachment. Tissue ingrowth surfaces can be incorporated intothe anchor structures to improve the duration and stability ofattachment.

Sleeve Assemblies

FIGS. 31D - 31E show a bypass sleeve embodiment in accordance with thepresent invention. Aspects of the present invention provide for sleeveassembly features and an anchor mount feature for quick, easy, andsecure attachment using a flexible endoscope. A sleeve safety ringfeature of the sleeve assembly increases patient safety by preventingpassage of the sleeve through the pylorus in the event of sleevedetachment. The sleeve and ring can be delivered via a flexibleendoscope.

Preferably the sleeve embodiment 31D comprises a polyurethane sleevewith holes 2400 at the proximal end to quickly and securely attach overand engage with the internal anchor mount feature. The proximal end ofthis sleeve embodiment is very compliant and can accommodate the stretchand collapsing nature of the gastro-esophageal junction. This sleeveembodiment also incorporates a silicone ring safety device which can beinflated after sleeve delivery and prevents sleeve passage through thepylorus in case of detachment.

Alternate sleeve assembly embodiments include:

-   -   a sleeve that incorporates a restriction or stoma 2500 at the        proximal end of the sleeve to encourage early satiety (FIG.        31G),    -   a sleeve mount feature which includes two compliant rings 2600        that allows the sleeve to float over the anchor mount features        to accommodate the contraction and expansion of the GEJ while        still providing for secure sleeve attachment to the soft-tissue        (FIG. 31G),    -   a sleeve mount feature which comprises j-hooks or loops to        engage with and mount on the anchor mount ring feature.

In one aspect of the invention, a stem-frame positioning system thatfacilitates circumferential placement and spacing of the anchors insidea tubular soft-tissue structure, such as the gastro-esophageal junction,is provided, as shown in FIGS. 31A-31C. This method consists of thefollowing steps:

-   -   Place two anchors 2700 at the GEJ at opposing positions (FIG.        31A).    -   Place the stem frame (FIGS. 31B-31C) over two tissue anchors        2700 to allow proper positioning of the other tissue anchors        2700.    -   Insert remaining tissue anchors 2700.    -   Remove the stem frame (FIG. 31B).    -   Place a sleeve 2900 around the anchors 2700 (FIG. 31E).

In one embodiment of the invention, the deflated balloon anchor 4028 isplaced within a slotted needle 4000 as shown in FIG. 32C. A pushrod4012, with a tip 4036 larger in diameter than the shaft of the pushrod4012, is also placed within the needle 4000 behind the balloon anchor4028 and the needle 4000 is then retracted until the deflated balloon4028 is delivered through the tip of the needle 4000 and subsequentlyinflated. The needle 4000 also includes a step 4032 at its proximal endfor depth control.

Mechanical Cuff-Link Soft Tissue Anchors

Aspects of the present invention disclose a mechanical cuff-link anchorwhich is a dual-ended flip-style anchor attachment structure which canbe transmurally deployed to soft-tissue via a small orifice, such as adelivery needle. The anchor is banana-shaped with an ellipticalcross-section. The large surface area of the anchor interfacing withsoft-tissue surfaces results in decreased stress concentrations. Therounded edges and curved profiles of the anchor also decrease stressconcentrations. Decreasing stress concentrations prevents pressurenecrosis and ischemia which result in anchor pull-out and failure. Thus,the anchor embodiments of the present invention provide strong,long-term attachment. In one embodiment, the anchor is a fixed lengthanchor such that over-tensioning that leads to pressure necrosis isprevented. The anchor length may be adjusted, in other embodiments, toaccommodate tissue thicknesses up to 25 mm. The small size of the anchorpermits delivery through a flexible endoscope. The anchor also includesa pinned connection between the strut and external anchor which allowsthe anchor and strut to be delivered via a needle and then deployed onthe external soft-tissue surface. Because no sutures are required indeployment the long-term embrittlement and fracture issues associatedwith sutures are avoided.

As depicted in FIG. 33, a preferred embodiment 3000 of the inventioncomprises an external curved, banana-shaped anchor 3016 about 10 mm longby about 1.5 mm wide and 1 mm tall, with an elliptical cross-section fora high surface area to delivery needle diameter ratio. In thisembodiment 3000, the anchor 3008 is comprised of high-strength, flexiblematerial such as PEEK. The anchor 3008 may also have a slot 3020 throughhalf of its length to receive a connection strut 3004. The anchor 3008can be delivered as shown in FIGS. 32A-32B via a small delivery needle4000 from the internal surface to the external surface of thesoft-tissue. After being delivered, the anchor 3008 flips to resistpull-out. A connection strut 3004 with slot or teeth features 3028 toengage the internal anchor 3024 is rotatably pinned to the banana-shapedanchor 3016. The strut 3004 is also delivered via the delivery needle4000 of FIGS. 32A-32B. The internal anchor 3024 of this embodiment maybe comprised of components, such as pins 3012 that elastically flex toengage the teeth 3028 of the connection strut 3004, that enable a quickand secure connection to the connection strut 3004, such that theinstalled anchor 3000 is effectively a one-piece assembly.

Alternate embodiments of the anchor include:

-   -   a monolithic external anchor and strut with a living hinge about        which to rotate the anchor and that connects quickly and        securely to the internal anchor,    -   an internal anchor that includes a mount ring or feature that        may be utilized to connect the device being anchored in        soft-tissue,    -   a connection strut that also includes a mount ring or feature        that may be utilized to connect to the device being anchored in        soft-tissue,    -   an internal anchor that is a monolithic anchor that can        elastically deform to accommodate the strut engagement features;        and    -   a fixed length connection strut between 2 mm and 25 mm in length        which positions the internal anchor at the predefined distance        away from the external anchor.

In one embodiment, delivery of the mechanical cuff-link anchor isachieved with the aid of a pushrod 4012 shown in FIG. 32A. The push rod4012 is advanced within the delivery needle 4000 behind the anchor 4004such that the anchor 4004 is pushed to the tip of needle 4000 and isdelivered through the slot 4020 at the tip of the needle 4000. In thisembodiment, the strut 4008 remains outside of the needle 4000 and onlythe anchor or T-tag component 4004 is advanced by the push rod 4012within the needle 4000.

In another embodiment, a pushrod 4012 has a well 4024 that bypasses thestrut component 4008 of the mechanical cuff-link anchor such thatpushrod 4012 pushes only the anchor or T-tag component 4004 as shown inFIG. 32B. In this embodiment, the entire mechanical cuff-link anchor,including the strut 4008 and T-tag 4004, are within the delivery needle4000. The pushrod 4012 is then advanced within the needle 4000 such thatthe well 4024 is advanced over the strut 4008 and the pushrod 4012pushes the T-tag component 4004 until it is delivered through the slot4020 at the tip of the needle 4000.

FIG. 34 shows a Molly anchor or radially expandable anchor embodiment2000, with a suture 2012 extending behind anchor 2000, deployed within adelivery needle 2004. A hollow pushrod 2008 advances behind the anchor2000 and pushes the anchor 2000 out of the tip of the needle 2004. Oncethe anchor 2000 exits the needle 2004 it expands and locks intoconfiguration. The expansion of the Molly anchor may be either passiveor active, depending on the preferences of the surgeon or clinicalrequirements. A passive expansion would be one in which the anchor ispre-formed into its expanded state and returns to the expanded statewhen deployed from the needle. An active expansion would be one in whichthe surgeon applies a force, such as a tensile force, to expand theanchor to an expanded state. The anchor may be locked in this expandedstate through plastic deformation of the bent ribs or through lockingelements such that it does not return to the retracted state.

When placing T-tag fasteners or other fasteners in the region of theGEJ, it is important to avoid other anatomical structures in thevicinity of the stomach and esophagus. One method for this is to createa safe space behind the GEJ for deploying the fasteners. One method toaccomplish this is described in the parent application, Ser. No.10/698,148. Alternatively, one can take advantage of the fact that theproximal stomach generally lies just below the diaphragm when thepatient is in a head-up position. Space will be created between thestomach and diaphragm into which transmural fasteners can be safelyplaced. This safe space can be increased by having the patient inhaledeeply while in a head-up position to push the stomach down with thediaphragm, then exhale to lift the diaphragm up off of the stomach.Preferably, the fasteners 250 will be delivered parallel to thediaphragm 252, as shown in FIG. 35, though other orientations arepossible. FIG. 35 also shows an optional stomach traction device 254deployed through the working channel of an endoscope 256 that helps tofacilitate safe deployment of the fasteners 250 in the GEJ region. Thetraction device 254 can be used to retract the gastric wall laterally254A and/or distally 254B to create a safe place for deployment of thefasteners 250. Due to anatomic variations and pathology, the position ofthe diaphragm relative to the stomach and GEJ should be confirmed priorto using this technique.

Alternatively or in addition, pneumoperitoneum can be used to create asafe space around the stomach and esophagus. Pneumoperitoneal pressurewill tend to collapse the stomach away from other surrounding organs andwould be balanced by the pressure used to endoscopically insufflate thestomach for improved visualization and access.

Other tactics to avoid other anatomical structures in the vicinity ofthe stomach and esophagus include the use of imaging techniques such asfluoroscopy, esophageal ultrasound imaging, external ultrasound imagingand/or Doppler imaging when placing fasteners. Alternatively or inaddition an “endoscopic compass” can be used to provide a reference fororienting the endoscope when using fastening devices. A small magnetizedneedle (i.e. a compass needle) is placed near the distal end of theendoscope where it can be viewed by the operator through the endoscope.A magnet is placed on the patient to provide a reference point for thecompass, for example the reference magnet can be placed on the patient'sback directly over the spine. The compass needle will point toward thereference magnet on the spine. Using the compass needle as a reference,the operator will be able to avoid inadvertently puncturing the aorta,which lies directly posterior to the esophagus.

The concept of the Veress needle can be adapted for avoiding puncturingother anatomical structures in the vicinity of the stomach and esophagusduring endoscopic attachment of devices near the GEJ. A Veress needle isa needle equipped with a spring-loaded obturator that is often used forinsufflation of the abdomen in laparoscopic surgery. A long, flexibledevice with a needle at the distal end and a spring-loaded obturatorwithin the needle would be used to safely puncture the gastric oresophageal wall. Once the needle has passed through the wall, thespring-loaded obturator advances automatically to avoid damage to anysurrounding tissues. A delivery cannula can be advanced over the needleand the needle can be exchanged with a fastener delivery device.Alternatively, this concept can be adapted directly into the fastenerdelivery device. A T-tag fastener or the like would be spring-loadedinto the lumen of a delivery cannula so that it would be ejected out ofthe lumen immediately after the cannula has traversed the gastric oresophageal wall.

Another method for avoiding deploying fasteners into the aorta wouldinvolve a small diameter needle with a flow detector (e.g. a Dopplerflow sensor) or pressure detector for detecting blood flow or bloodpressure. Alternatively, a flow detector or pressure detector can bemounted on a separate guidewire inserted through the needle. The flowdetector can be used to detect blood flow before the wall of the aortais punctured. Alternatively, if backflow of blood or blood pressure isdetected, indicating that the needle has punctured the aorta, the needlewill be withdrawn and a fastener will not be delivered at that site. Thesmall diameter puncture in the aorta should heal without complications.

Alternatively or in addition, the organs and other anatomical structuresin the vicinity of the stomach and esophagus can be protected duringendoscopic attachment techniques by using a depth stop on the needle ordelivery cannula to prevent it from penetrating farther than necessaryto traverse the gastric or esophageal wall. Examples of fastenerdelivery devices with a depth stop to protect nearby organs andstructures are described in U.S. provisional patent application60/569,442.

One method for placing an implantable device within a patient's body hasbeen described as a “parachuting” technique. In this technique, multipleelongated sutures are sewn through the tissue where the device is to beimplanted with the ends of the sutures extending out of the patient'sbody. The ends of the sutures are passed through a sewing ring orsimilar structure on the device while the device is still outside of thepatient's body, then the device is parachuted or slid into place alongthe sutures. The device is typically secured in place by knotting theelongated sutures with the help of a knot pusher or similar device andthen the sutures are cut off close to the knots. U.S. provisional patentapplication 60/534,056 describes a variation of this method forimplanting a device within a patient's digestive tract using T-tagfasteners. Alternatively, suture locks such as those described in U.S.Pat. No. 4,235,238 or those used in the BARD Endocinch system can beused to secure the suture prior to cutting.

When parachuted into place along the sutures, the device may be foldedor compressed to pass through the esophagus or through a delivery tubeplaced in the esophagus. When using this parachuting technique it isdesirable to minimize the friction between the device and the sutures.This can be done by using a low friction material or a low frictioncoating on the sutures and/or the device. This is also done bydimensioning and/or orienting structures, e.g. holes, to guide theparachuted device to reduce friction.

FIG. 36 shows an implantable device 120 being implanted at the GEJ usinga parachuting technique. One method of using a fastener delivery device150 for placement of an implantable device 120 by the parachutingtechnique is disclosed in U.S. utility patent application Ser. No.11/025,364, previously incorporated by reference herein.

Alternatively, the device 120 may be partially parachuted into place,meaning that 2-4 parachute sutures are used to slide the device 120 intoposition with the proper orientation. Then additional fasteners, forexample T-tag fasteners, are delivered to complete the attachment of thedevice 120 to the tissue.

If suture tails are delivered through a closed lumen (e.g. in orattached to an endoscope), the lumen must be removed from around thesuture tails before a device can be parachuted over the sutures if thedevice is too large to pass through the lumen. This can present achallenge related to maintaining the organization of the suture tailsand preventing confusion, crossing, winding and/or tangling of thesuture tails. If T-tag fasteners and their suture tails are passedexternally e.g. through an external lumen with a longitudinal slot or ina non-enclosed rail type system, the suture tails can be managedexternal to the lumen used to place the T-tag fasteners and external tothe scope. This facilitates manipulation of the scope, simplifies scopeexchanges and simplifies suture tail management.

Suture tail management external to the scope or an enclosed lumen can becombined with suture holders external to the patient, similar to thoseused for parachuting replacement heart valves into place. Snugging thesutures as described above is simpler when the suture tails are externalto the scope, as is avoidance of crossing, winding and/or tangling ofthe suture tails. Suture holders, such as slots, clamps or clips, can becombined with a mouth guard for organizing the sutures during a peroralparachuting procedure.

One aspect of suture tail management is that it must happen from one endof the system to the other. Therefore, the method and apparatus mustaddress this issue. For example, after placement of a T-tag fastener, aslight tension on the suture tail can hold the suture against the wallof the lumen or in a straight position where it is less likely totangle. Apparatus can include means to maintain tension while allowingscope movement and manipulation, e.g. tension from a long soft spring,an elastic band or a spring-loaded reel.

Sometimes, when performing an endoscopic procedure, an overtube is usedto line the esophagus and protect it from damage due to insertion andmanipulation of the endoscope and related tools and devices. Otherpractitioners prefer to avoid the use of an overtube. In either case, itmay be desirable to secure an implant being parachuted down theesophagus in a collapsed, folded or otherwise reduced configuration. Amajor issue when parachuting a device into place is friction between thedevice and the sutures, and collapsing or folding the device mayexacerbate the problems with friction.

The following method is intended to reduce the problems with frictionbetween the device and the sutures when parachuting a device through theesophagus. The method allows the device to be parachuted through theesophagus in a folded configuration, while it also allows the sutures topass through the device while it is in an unfolded position. Inaddition, the method allows the sutures to be pulled through the deviceone at a time, which further reduces the problems with friction. Thismethod can be used, for example, with the t-tag and/or t-tag deliverysystems described herein.

1) Place fasteners (e.g. 6-10) in or through gastric wall with suturetails extending out through the patient's mouth; the sutures should havea length that is about 100-140 cm longer than required to exit themouth;

2) thread suture tails through the device to be parachuted into place,e.g. an implant mounting ring;

3) slide the device down the sutures until it is just outside of thepatient's mouth, with 100-140 cm of suture extending beyond the device;

-   -   4) fold or collapse the device and secure it in the collapsed        position, e.g. with a removable sack or tied with a suture;

5) slide the device through the esophagus or the scope overtube (thedevice is not slid down the sutures, but instead the sutures are allowedto move with the device into the esophagus with the ends of the suturesremaining outside the patient);

6) once the device is through the esophagus and inside the patient'sstomach, the device is release from its collapse position, and anyrestraining device that was used is removed perorally;

7) while controlling the device (e.g. with a grasper), and preferablyunder direct vision, pull each suture through the device until all theslack is removed and the device is at or near its intended position inthe stomach;

8) position and secure the device in its intended position in thestomach.

FIGS. 37A-37G illustrate a dual-headed T-tag fastener 100 that isespecially adapted for attaching devices that are parachuted into placewithin a patient's digestive tract. Alternatively, the dual-headed T-tagfastener 100 can also be used to attach cuffs, bypass tubes or otherdevices that are not parachuted into place as well as attaching tissueto tissue. The T-tag fastener 100, which is shown being deployed in FIG.37G, has a primary T member 102 that is pivotally attached near itscenter to the end of an elongated suture 104. The primary T member 102has an undeployed position wherein the primary T member 102 isapproximately parallel to the body of the elongated suture 104 and adeployed position wherein the primary T member 102 is approximatelyperpendicular to the body of the elongated suture 104. A secondary Tmember 106 is pivotally attached near its center to the body of theelongated suture 104 at a position spaced apart from the primary Tmember 102. The secondary T member 106 has an undeployed positionwherein the secondary T member 106 is approximately parallel to the bodyof the elongated suture 104 so that it presents a low profile so that adevice can be slid in place along the elongated suture 104 and over thesecondary T member 106 and a deployed position wherein the secondary Tmember 106 is approximately perpendicular to the body of the elongatedsuture 104. The fastening gap, that is distance between the primary Tmember 102 and the secondary T member 106, may be fixed or, optionally,the secondary T member 106 may be slidable along the body of theelongated suture 104 to adjust the fastening gap.

FIGS. 37A-37F are detail drawings of the secondary T member 106 of theT-tag fastener 100 of FIG. 37G. FIGS. 37A-37B show two variations of thesecondary T member 106 alone. FIG. 37C-37E show three variations of thesecondary T member 106 in the undeployed position wherein the secondaryT member 106 is approximately parallel to the body of the elongatedsuture 104 so that it presents a low profile so that a device can beslid in place along the elongated suture 104 and over the secondary Tmember 106. Various securing members, including a stopper member 107(FIG. 37D), knot 109 (FIG. 37C), crimp 111 (FIG. 37E) are shown. FIG.37F shows the secondary T member 106 in the deployed position whereinthe secondary T member 106 is approximately perpendicular to the body ofthe elongated suture 104. In the embodiment shown, the secondary Tmember 106 is preferably constructed from a polymer, a rigid tubularmaterial, for example NiTi, Ti or stainless steel tubing. A first end108 of the secondary T member 106 is tubular in configuration and thebody of the elongated suture 104 passes through the lumen 112 of thetube. A second end 110 of the secondary T member 106 is cut away aroundapproximately 60-180 degrees of its perimeter along one side to allowthe secondary T member 106 to pivot or swivel relative to the body ofthe elongated suture 104 as shown in FIG. 37F. The secondary T member106 is pivotally attached to the body of the elongated suture 104, forexample by a stopper structure, a knot in the suture 104, crimping,adhesive or other attachment means. Attachment of the T member 106 tothe suture will optionally prevent motion of the T member in eitherdirection. Restriction of motion in the proximal direction will enablethe T member to function to hold a structure in place, as shown in FIG.37G, while restriction of motion in the distal direction will facilitatepassage of the T member 106 through a structure as shown in FIG. 37G.

In some embodiments, a stopper member 107, or other securing means suchas an adhesive, crimp or knot may be used alone or in combination tocreate a tapered or gradual proximal transition, which may facilitatepassage of the secondary T member 106 through other structures as shownin FIG. 39. Optionally, the secondary T member 106 may be slidable alongthe body of the elongated suture 104 in order to adjust the fasteningdistance. In this case, a secondary securing means would be applied tothe T member 106 once it is in place. This could be a knot, crimp,adhesive, stopper member 107, or other securing means known in the art.In some embodiments more than one stopper will be appropriate, e.g. oneto prevent distal motion and one to prevent proximal motion.

FIGS. 38-43 show the steps for deploying a dual-headed T-tag fastener100 of the type shown in FIGS. 37A-37G. FIG. 38 shows the T-tag fastener100 positioned within the lumen 118 of a delivery cannula 114 with theprimary T member 102 and secondary T member 106 in the undeployedposition. The elongated suture 104 extends through the lumen 118 and outthe proximal end of the delivery cannula 114. The delivery cannula 114can be part of a fastener delivery device, which is explained in moredetail below. The delivery cannula 114 has a sharpened distal end 116that is used to penetrate the tissue that is to be fastened, for examplethe gastric or esophageal wall in the vicinity of the GEJ. The primary Tmember 102 is ejected from the delivery cannula 114 and deployed behindthe tissue.

FIG. 39 shows the T-tag fastener 100 with the primary T member 102deployed. The delivery cannula 114 is removed by withdrawing it with theenclosed secondary T member 106 through the tissue and then furtherwithdrawing the cannula 114 from the proximal end of the suture 104.Then the primary T member 102 is snugged against the tissue with alittle tension on the suture 104 in preparation for parachuting orotherwise attaching a device into place. Alternatively, the deliverycannula 114 can be passed through two or more layers of tissue, two ormore devices or a combination of layers of device and tissue to achievethe configuration similar to that shown in FIG. 41.

FIG. 40 shows the T-tag fastener 100 after the delivery cannula 114 hasbeen removed. After a sufficient number of fasteners have been placed inthe tissue, the device to be implanted can be parachuted or otherwisedeployed into place by passing the sutures 104 through the device andsliding the device down the sutures 104 until it is in contact with thetissue. The device is slid over the secondary T member 106, which isstill in its undeployed position.

FIG. 41 shows the T-tag fastener 100 after a device has been deployed,for example by being parachuted into place. Tension is applied to theelongated suture 104 (and, optionally, a pushing force is applied to thedevice) to provide clearance for the secondary T member 106 to rotate orswivel to the deployed position. FIG. 42 shows the T-tag fastener 100with the secondary T member 106 being deployed. The tension of thesuture 104 is released to allow the secondary T member 106 to fullydeploy and the suture 104 is trimmed proximal to the secondary T member106. FIG. 43 shows the T-tag fastener 100 fully deployed. Optionally, alateral force may be applied to the secondary T member 106 to assistdeployment.

The fastening gap determines the tension on the suture 104 and hence thepressure on the tissue exerted by the primary T member 102 and theimplanted device 120. Optionally, this gap can be variable and orchangeable as described herein.

Other configurations of fasteners and fastener delivery devices known inthe art can be used in conjunction with the present invention. Forexample, U.S. Pat. No. 4,235,238 describes various fasteners andendoscopic fastener delivery devices for use in the gastrointestinalsystem. Other attachment and /or parachuting approaches can be used withthese dual t-tag fasteners to secure devices, for example, toplications.

Another method for deploying a T-tag is shown in FIG. 44A-44E and isreferred to herein as the Sewing Method.

By way of example, the sewing method is described below using theembodiment of the sewing device shown in FIGS. 44A-44E.

Method Steps:

The flexible endoscope 5004 is maneuvered to the target tissue.

The needle catheter 5008 is advanced through the biopsy channel of thescope 5004.

The split protective needle sheath 5012 opens as the needle 5016 emergesfrom the tip of the scope 5004.

The needle 5016 is plunged into the gastric tissue 5020 to a depth of2-3 mm, with the open protective needle sheath 5012 acting as a stop tocontrol the depth of needle 5016 penetration.

The pusher 5024 is advanced to eject the T member 5028 of the T-tagfastener 5032 from the distal end of the needle 5016 just beyond theserosal surface 5036.

The needle catheter 5008 is withdrawn into the biopsy channel of thescope 5004 and the split protective needle sheath 5012 closes.

The suture 5040 is secured by tying or by pushing a suture lock 5044onto the suture 5040.

Optionally, the device may be configured to perform the sewing, lockingand cutting of the suture in a single action. If the suture is passedthrough an open locking mechanism over the needle, the suture could belocked by pushing the catheter, sheath and lock forward.

Delivery cannula devices/systems (hereinafter delivery cannula) can beconfigured for the delivery of multiple T-tag or other fasteners. Inparticular these delivery cannulae allow placement of multiple T-tags(or in the case of a dual-headed T-tag fastener, primary T members)through a layer of tissue and/or a device while facilitating themanagement of multiple fastener suture tails.

A delivery cannula can include some or all of the following components,which will be described in more detail below in relation to specificembodiments of delivery cannulas:

penetrating cannula to penetrate the tissue and deliver the T member ofthe T-tag;

transit cannula to delivery the T-member of the T-tag to and into theproximal end of the penetrating cannula;

loading cannula to load or position the T member of the T-tag at andinto the proximal end of the transit cannula;

garage or protective cannula to provide a shield into and out of whichthe penetrating cannula can be advanced and retracted when appropriate;

pusher to perform any or all of the functions related to advancing aT-tag through the loading cannula, through the transit cannula, throughthe penetrating cannula and expelling the T-tag out of the penetratingcannula.

In a basic delivery cannula embodiment, the first components are asingle elongated hypodermic tube with a sharpened distal tip as thepenetrating cannula and a wire or rod as the pusher. This type of devicegenerally delivers a single fastener before being withdrawn to clear thesuture tail from the tube. A more complicated delivery cannula issimilar to the above, but incorporating a longitudinally slottedhypotube. This allows the tail/suture of the T-tag fastener to beexternal to the hypotube and allows a smaller diameter hypotube as wellas other suture/tail handling advantages. In this case theabove-mentioned penetrating, transit and loading cannulas are embodiedin the single cannula.

In all the delivery cannulas, the penetrating cannula must be movablerelative to the tissue through which it penetrates for T-tag fastenerdelivery. In a basic delivery cannula, the penetrating cannula will movein conjunction with the transit cannula and loading cannula. In morecomplex delivery cannulas, the penetrating cannula will move relative tothe transit cannula and/or loading cannula.

The delivery cannula can be configured to be used:

1) within the biopsy channel of an endoscope;

2) attached to the exterior of an endoscope;

3) as a stand alone device with a separate means ofaiming/visualization.

The delivery cannula should include means to keep the penetratingcannula point from inadvertently damaging tissue or the device throughwhich it is delivered. For example, a Varess needle style obturator orother obturator can be used. The obturator must be removed to deliverthe T-tag fastener through the lumen of the penetrating cannula. Anexternal needle protector, or garage, may also be used, which has theadvantage that it would not have to be removed for T-tag fastenerdelivery. A slotted garage could have additional advantages for T-tagfastener delivery. A penetrating cannula that is spring loaded within agarage where it only exits the garage under the impetus of a pusher inpreparation to penetrating tissue would also have certain advantages.

Retracting the penetrating cannula into the biopsy or instrument channelof the endoscope will protect the tissue from inadvertent damage, butnot the lining of the instrument channel. To protect the biopsy channel,the penetrating cannula could be retracted within the transit cannula orinto a structure (garage) located at the juncture of the penetratingcannula and the transit cannula.

As an alternative to the slotted hypotube previously mentioned, amagnetic or mechanical rail system can be used in place of or incombination with the transit cannula. In this case, the pusher capturesthe primary T member 102 for delivery to the penetrating cannula. Thepusher is magnetically or mechanically coupled to the transit cannula.FIGS. 45A-45C show possible configurations for a rail-mounted deliverydevice for deploying a T-tag fastener mounted on the exterior of aflexible endoscope. FIG. 45A shows a rail 140 mounted to the exterior ofa flexible endoscope 142 using a plurality of mounting clamps 144. Inone embodiment, the rail 140 may be configured as a slotted tube.Alternatively, the rail 140 of FIG. 45A could incorporate a mechanicalcoupling 146 as shown in FIG. 45B or magnetic coupling 148 as shown inFIG. 45C. A delivery cannula, such as described below, will be slidinglymounted to the rail 140 using one of the coupling mechanisms described.

Similarly, a smaller diameter, short length slotted hypotube transitcannula can be used with a monorail T capturing pusher as a means totransfer the T-tag fastener to the penetrating cannula. In this context“monorail” refers to a short distal coupling section such as those usedto couple a monorail or rapid exchange catheter to a guidewire. In thiscase, the monorail transit cannula, such as shown in FIGS. 45B-45C,could be coupled to a rail 140 as in FIGS. 45A-45C. With thisconfiguration, the transit cannula, rather than extending the fulllength of the delivery cannula, would be a short length and would movefrom a position at the distal end of the loading cannula to a positionat the proximal end of the penetrating cannula. This short lengthtransit cannula length could be approximately half to two or three timesthe length of the T member. The term monorail T capturing pusher refersto a pusher alone or in combination with the transit cannula.

Having elongated suture tails extending out of a patient's mouth (orother orifice) with an associated need to pass devices over the suturetails can be cumbersome if standard “exchange length” techniques areapplied. A monorail style device could be used through an internal orexternal endoscope lumen or independent of the endoscope. This type ofdesign allows control of the T member in a short slotted cannula whilethe majority of the length of the suture tail would be external to anelongated transit cannula. This may also provide an easier path for thelong suture tail as when an elongated slotted cannula might not maintaina slot free of obstruction when the endoscope was subjected to flexion.

If the monorail portion of the device extends out of the lumen of theendoscope, the monorail portion can optionally be of sufficient lengthto partially remain within the endoscope lumen to provide improvedsupport and manipulation capability.

A two-channel endoscope can be used to deploy a series of T-tagfasteners. In one method of using such a 2-channel endoscope the T-tagfasteners are delivered through the first channel of the scope. Thedistal T members of the fasteners, individually or collectively, areplaced outside the distal end of the scope. A delivery device is placedin the second channel and positioned near the distal tip of the scope. Acapture/pusher device is passed through the first delivery cannula and asingle distal T member is captured and drawn into the delivery cannula.The penetrating cannula of the delivery device is preferably slotted.The delivery device is used to deploy a series of T-tag fasteners intothe tissue in the manner described above. The steps of T member captureby the pusher, drawing into the delivery cannula and deployment arerepeated for each T fastener. As the endoscope is removed from thepatient, the multiple suture tails of the T-tag fasteners are drawn outof the distal end of the first channel of the endoscope. The suturetails should be long enough to extend out of the patient's body, forexample out through the patient's mouth. Labeling, color-coding or othermeans may be used to help organize the suture tails. A device can bethreaded onto the proximal ends of the sutures and parachuted intoplace. Optionally, the ends of the suture tails may have needlesattached to facilitate passing the sutures through preformed holes or asewing ring on the device.

FIG. 46 show another embodiment of a delivery device 150 for deploying aT-tag fastener 100 mounted on the exterior of a flexible endoscope 142.FIG. 46 shows a penetrating cannula 114, which may be made of hypotube,17-20 gauge, regular, thin or extra thin wall, 304 stainless steel orNiTi. The penetrating cannula 114 has a sharpened distal tip 116, whichmay be a short or standard hypodermic needle bevel, and a longitudinalslot 115, which is preferably 0.008-0.020 inch wide and around 0.5-1.5inches in length.

A tubular member that functions as a garage or protective shield 152 forthe penetrating cannula 114 may be mounted externally on the endoscope142, e.g. with one or more interference fit mounting clips 144. Thegarage 152 has an ID larger than the penetrating cannula OD to allowsliding of the penetrating cannula 114 relative to the garage 152 withclearance and/or a slot 154 for the suture tail. The penetrating cannula114 may be spring mounted in the garage 152, so that the penetratingcannula 114 retracts into garage 152 automatically or upon withdrawalfrom tissue.

The distal end of the transit cannula 156 connects to the proximal endof the garage 152. The garage 152 and the transit cannula 156 may beconstructed of separate pieces of tubing as shown or, alternatively,they may be constructed of one continuous piece of tubing. The transitcannula 156 has a diameter the same or slightly larger than thepenetrating cannula 114, optionally slotted, mounted externally onendoscope 142, e.g. with one or more interference fit mounting clips144. In conjunction with the pusher 122, it delivers the T-tag fastener100 to the penetrating cannula 114 while it is positioned in the garage152. Preferably, it is designed to prevent binding when the endoscope142 is deflected, including retroflexed, e.g. with a bellows or otherflexible structure 158 at major flex points. The transit cannula 156 maybe ferrous/magnetic for magnetic coupling between the transit cannula156 and pusher 122. Alternatively, it could be a mechanical coupling oralternatively could use a monorail configuration.

A loading cannula or other fastener loading mechanism attaches to thescope biopsy port or scope handle. The loading cannula may load thepusher with T-tag fasteners individually or may feed T-tag fastenersfrom a magazine to pusher for delivery of multiple tags.

FIG. 47 is a detail drawing of a pusher 122 for use with a T-tagfastener delivery device 150. The pusher 122 sequentially advances thepenetrating cannula 114, then deploys the T-tag fastener 100. The pusher122 is preferably a stainless steel or NiTi wire, 0.008-0.025 inchdiameter. Interface knobs 123 of diameter slightly smaller than the IDof transit cannula 156 are placed at intervals along the pusher 122 toallow free movement when the transit cannula 156 is flexed. Optionally,they can be magnets to assist coupling with the transit cannula. Thisembodiment shows a distal socket 121 to capture the T member of theT-tag fastener 100. In some embodiments a loose fit for easy release maybe desired, while in others a press fit for retention and a secondarymeans to assist in release may be indicated. The distal socket 121 mayhave an optional slot for the suture tail. A spring loaded interface 125engages the proximal end of the penetrating cannula 114 when the distalend of T-tag fastener 100 reaches the proximal end of the penetratingcannula bevel 116. The pusher 122 then advances the penetrating cannula114 until it is fully extended and reaches a stop, the spring 124 thencompresses and distal T member 102 is advanced out of penetratingcannula 114, pusher 122 is retracted leaving the T-tag fastener 100attached to the tissue. The pusher 122 is then retracted and thepenetrating cannula 114 then retracts. The pusher 122 may wind up onto areel or drum attached to the loading cannula.

FIG. 48 shows a proximal end of a delivery device with a magazine 160for sequentially delivering multiple T-tag fasteners 100. In thisembodiment the transit cannula 156 passes through the biopsy channel ofthe endoscope 142. The proximal end of the transit cannula is near thebiopsy port of the scope where a loading cannula 162 is attached with arotating magazine 160 to feed T-tags 100 one at a time into the loadingcannula 162. The loading cannula will have a slot to receive the Tmember and a coaxial narrower slot to allow passage of the suture tailof the T-tag. At the proximal end of the loading cannula 162 is shown aretractable pusher 122 configured to be coiled by a reel mechanism 164to control pusher advancement and retraction. In this embodiment, thedistal socket 121 on pusher 122 is retracted proximal to the magazine160, the magazine is then rotated to position the next T-tag at theloading cannula 162 and then the pusher and attached socket areadvanced.

The T-tag fastener delivery device could use any long tail T-tagfastener, including the dual headed T-tag fastener described herein andin the prior application.

Other aspects of T-tag fastener delivery devices 150 include:

1) ease of use related to exchange of devices;

2) management of the tails 104 of previously inserted T-tag fasteners100.

If used through an endoscope lumen or external to the endoscope, thedelivery cannula or its components would be flexible to accommodate theflexing and articulations of the endoscope. Flexibility can be provided,for example, by the following features singly or in combination, overthe full length of the device/component or at selected locations:

1) flexible and/or elastic polymeric material (e.g. PU, PE, PEBAX);

2) a superelastic metal material (e.g. NiTi);

3) a coiled or braided material (e.g. 304 stainless steel with orwithout a polymer coating);

4) a radially slotted material (e.g. 304 SS or NiTi);

5) a bellows (e.g. 304 SS or NiTi).

Longitudinally slotted cannulas have advantages related to cannulasizing and also for delivering multiple T-tag fasteners. The suturetails of each T-tag fastener can exit the cannula through the slot afterthe fastener is deployed so that they will not damage or interfere withsubsequently deployed fasteners. A parachute T-tag fastener or a snapT-tag fastener, described below, can have particular advantages in thisregard.

FIG. 49A shows a snap T-tag fastener 130 with a T member 102, a suturetail 104 attached to the T 102, and a snap member 134 attached to thesuture tail 104. FIG 49B shows the snap T-tag fastener 130 of FIG. 49Awith the cap 132 in place. Materials and dimensions of the snap 134 andcap 132 are optimized for ease of snapping (i.e. pushing cap 132 oversnap 134) while maintaining sufficient retention force with the fastener130. Snap force should be less than 1 kg and preferably less than 200gm. Retention force should be greater than the snap force and preferablygreater than 2.0 kg. The cap 132 is not threaded onto the suture tail104 until after the suture tail 104 has been threaded through the device120 to be parachuted or otherwise deployed. The features and propertiesof the snap T-tag fastener 130 can be combined with the features andproperties of other T-tag fasteners described herein.

One aspect in common between the parachute T-tag fastener 100 and thesnap T-tag fastener 130 is the presence of a relatively large retentionelement (i.e. the proximal T member 106 or the snap 132) on the suturetail 104 in proximity to the distal T member 102. With appropriatedimensioning, the proximal T member 106 of a parachute T-tag fastener100 or the snap 132 of a snap T-tag fastener 130 remains outside theslotted penetrating cannula 114 and facilitates positioning the suture104 outside of the cannula 114, as shown in FIGS. 51B-51D. Use of adelivery cannula system where all components (penetrating cannula,transit cannula, loading cannula) are similarly slotted allows multipleT-tag fasteners to be placed without interfering with the suture tailsof previously placed fasteners. Also, a rail system as described hereincan be combined with a slotted penetrating cannula to accomplish asimilar result.

The interface between the proximal end of the keyed wire 174, the T-tagfastener cartridge magazine and the pusher assembly 182 can all becombined in a deployment handle assembly similar to the one shown inFIG. 48, which could optionally deploy both the keyed wire and thepusher wire assembly, or the pusher wire assembly alone, from one ormore reels. The deployment handle could be secured to the proximal endof an endoscope lumen or external to the endoscope control handle if thegarage assembly is secured externally to the scope on its distal end. Ifthrough the endoscope lumen, the keyed wire would then be extendedthrough the scope (optionally, before being placed into the patient.)The magazine could then be attached to the handle and a single cartridgeadvanced into a loading area where the pusher wire would be engage, thenthe cartridge and pusher wire, mated together, could be advanced ontothe proximal end of the keyed wire.

In this embodiment, once the loading cannula and cartridge are mated,further advance of the mated cartridge and pusher rod would result in:

1) transit of the T-tag fastener in its cartridge to the distal end ofthe endoscope;

2) penetrating cannula extension;

3) holding and/or advancing the penetrating cannula when tissue ispierced (could be simultaneous with step (1)

4) holding penetrating cannula extended when T-tag fastener is deployed.

Retraction of the pusher rod would:

1) allow retraction of the penetrating cannula through the tissue;

2) pull the cartridge in a proximal direction to the proximal end of theendoscope (an interface e.g. mechanical or magnetic would be required);

3) position the cartridge for being expelled into a storage chamber.

When placing T-tag fasteners it can be beneficial to orient the Tmembers in a specific direction relative to the anatomy. Two approachesare discussed:

1) orientation by delivery cannula;

2) orientation by pusher.

If a non-slotted penetrating cannula is used, then an oriented pusher orkeyed cannula or keyed pusher and keyed T member can be used to controlthe orientation of the T member as it exits the delivery cannula. FIGS.50A-50D show an example of a method of delivery orientation control thatinvolves a keyed pusher 320 with a mating keyed portion 321 on theproximal end of the T member 102. In this case the pusher key 320 canalso have a keyed delivery cannula 114 so the directional orientation isbased upon the delivery cannula orientation. If the pusher 320 is notkeyed to the delivery cannula 114, rotation of the pusher 320 may besufficient to determine the directional orientation of the T memberdelivery. A lubricious coating on the pusher shaft may facilitaterotational control.

Use of a slotted delivery cannula with the suture tail of the T-tagfastener positioned through the slot can maintain orientation of the Tmember as it passes through the delivery cannula. This may be sufficientto orient the T member, but the suture tail will generally exit the slotbefore the T member is fully deployed. Keying the proximal portion ofthe T member to the slot can improved control of orientation duringdeployment.

FIGS. 50A-50D illustrate a simplified view of delivery of a T-tagfastener showing only the T member 102 of the T-tag fastener and thedelivery cannula 114 with pusher 320 therein. In actual application, theentire delivery assembly would include an endoscopic delivery device(not shown), with the delivery cannula 114 deployed through the workingchannel of the endoscopic delivery channel. Also, in actual applicationthe T-tag fastener would attach an attachment device such as a cuff to agastrointestinal sleeve device through a grommet or hole in the cuffand/or sleeve device.

As shown in FIGS. 51A-51D, this can be accomplished by using a flattenedportion 103 extending from the proximal end of the T member 102 that canserve as a key that engages the slot 115 and maintains the orientationof the T member 102 as it rotates during deployment. To deploy thisT-tag fastener, it is helpful to apply tension to the suture tail 104while slowly advancing the pusher 136 to cause the T member to rotateand lay against the tissue before the pusher 136 ejects the flat portion103 from the delivery cannula. To help orient the T member 102, thepusher 136 can be configured with an interface knob head 138 having aslot 137 that engages the flat portion 103 of the T member 102 and holdsit aligned with the slot 115 in the penetrating cannula 114.

Another aspect of the T-tag fastener delivery device shown in FIGS.51A-51B is that is shows another means to force or maintain the suturetail 104 external to the slotted penetrating cannula 114. The pusherassembly is configured to exclude the suture tail 104 of the T-tagfastener from the slot 115 of the slotted penetrating cannula 114 by thesizing of interface knob head 138 and, optionally, one or more otherinterface knobs 123 positioned along the pusher rod 136.

The T-tag fastener delivery device may have a fixed orientation withrespect to the endoscope. Preferably, a visual indication of thedelivery device orientation is provided for the endoscope operator.Alternatively, the delivery device may be rotatable with respect to theendoscope. This will require a mechanism for controlled rotation of thedelivery device, e.g. a rotating shaft with gears to transmit therotation to the delivery cannula, and a visual indication that changesto indicate the rotational orientation of the delivery cannula. With avideo endoscope, this can be done electronically and indicated on theviewing monitor.

It is also possible to orient a T member 102 of a fastener afterinsertion. As shown in FIG. 52A, an attachment spacer or standoff 322that is part of the fastener could be configured to transmit rotationfrom the delivery device or another tool 324 to the T member 102.Coupling structures 326, 328 can be incorporated on the distal andproximal ends of the standoff 322. The coupling structure 326 at thedistal end of the standoff 322 would be configured to engage thedeployed T member 102 and the coupling structure at the proximal end 328of the standoff would be configured to mate with the delivery device324, which will have a rotational drive mechanism. The standoff 322would transmit rotation from the drive mechanism to the T member 102 asshown in FIG. 52B and after the delivery device 324 is removed thestandoff 322 will serve as a spacer between the T member 102 and theattached device.

Similarly, the T member can be oriented directly by a rotational drivetool 330 that is passed over the suture tails and through the tissue,where it engages the side of the T member 102 to transmit rotation tothe deployed T member 102 as shown in FIG. 53. The tool 330 is removedonce the T member 102 has been rotated to the desired orientation.

Rollers, a low friction coating or other material or structure on the Tmember of the fastener would allow the fastener to slide on the serosaand thereby direct itself to a desired orientation. A roller or lowfriction material on the T member would also facilitate reorienting theT member to a desired orientation using a rotational drive tool asdescribed above.

One other aspect of T-tag fastener delivery is the potential for a Tmember to pass proximally through the track formed by the penetratingcannula rather than rotating to be parallel to the tissue surface asdesired. In many cases the connection of the T member and the stem caninduce rotation of the T member. If the T member is attached to a suturetail, for example as shown in FIG. 51A, other means may be desirable toinduce T member rotation. The structures shown in FIGS. 50A-50D and51A-51D can be used, with or without orientation control, to induce Tmember rotation and avoid inadvertent retraction of the T member throughthe tissue track.

One of the challenges when performing endoscopic suturing, stapling orother types of attachment, e.g. with T-tag fasteners, is that the tissuetends to move away from the attachment device. A separate grasper can beinserted through an instrument lumen in the endoscope for holding thetissue, but this approach has its drawbacks because it is very difficultto achieve a good cooperation between the two instruments. To facilitateendoscopic attachment methods, a better cooperation can be achieved whenan attachment device is combined with or otherwise mechanically linkedto a grasper.

In one embodiment shown in FIG. 54A, the combined instrument 400includes a flexible grasping forceps 416, for example a rat-toothgrasper, with an opening 402 through the jaws 404 of the grasper.Coaxial with the jaws 404 of the grasper 416 is a lumen 406 for passingan attachment device 408 (shown extended) through the opening 402 in thejaws 404. The grasper operating mechanism must be modified toaccommodate the coaxial instrument lumen 406. The attachment device 408may be an endoscopic suturing device, a stapler, a T-tag fastenerdelivery device or other known endoscopic attachment device.Alternatively, the lumen 406 for passing the attachment device may exitthe shaft beside the jaws 404 of the grasper, potentially simplifyingthe construction of the grasper operating mechanism and obviating theneed for an opening in the jaws. In another alternative configuration,the attachment device may be integrated into the combined instrument.

In another embodiment shown in FIG. 54B, the combined instrument 400includes a corkscrew-type grasper 410 with a lumen 406 for passing anattachment device 408 (shown extended) coaxial with the opening 412through the center of the corkscrew grasper 410.

In another embodiment shown in FIG. 54C, the combined instrument 400includes a grasper 416 with multiple curved needles 414 that penetratethe tissue in opposing directions to grasp the tissue. Coaxial with thegrasper 416 is a lumen 406 for passing an attachment device 408 (shownextended) between the curved grasping needles 414.

The combined instrument 400 is introduced endoscopically and the distalend is maneuvered into contact with the tissue to be attached. Thegrasper 416 is actuated to hold the tissue and the attachment device 408is passed through the lumen to deliver a suture needle or fastener intoor through the tissue. Because the grasper 416 and the attachment device408 are so closely linked, the tissue cannot move out of the way of theattachment device 408, allowing the suture or fastener to be deliveredthrough the tissue reliably and efficiently.

Alternatively or in addition, a vacuum coupling cuff on the distal tipof the endoscope including at least one radially outwardly directedcavity in communication via a vacuum lumen with a vacuum source can beused to allow vacuum holding of the tissue during attachment.

In some applications of the T-tag fastener, it will be advantageous toprovide different configurations for the T member(s). FIGS. 55A-55H showtop views of some possible T member configurations. FIG. 55A shows astraight bar-shaped T member. FIG. 55B shows an X-shaped T member. FIG.55C shows a Y-shaped T member. FIG. 55D shows a V-shaped T member. FIG.55E shows an A-shaped T member. FIG. 55F shows a T-shaped T member. FIG.55H shows a circular or disc-shaped T member. The X, Y, V, A andT-shaped members may optionally be elastically deformable or pivotableat the center to provide a low insertion profile. FIG. 55B shows anexample of such a pivot. These configurations of T member will providegreater anchoring force and/or reduced pressure on the tissues wherethey are attached. Although these T members have differentconfigurations in the top view, they will still have an approximatelyT-shaped configuration in the side view, as shown in FIG. 55G, which isa side view of the T-shaped T member in FIG. 55F.

Expandable or swellable T members also have advantages for greateranchoring force and/or reduced pressure on the tissues where they areattached. A T member could be configured of a material that is initiallysmall and/or soft for insertion of the T members. After insertion, the Tmember would expand or swell and then harden in the expandedconfiguration. This could result from a chemical reaction that isinitiated by absorption of water or another reactant. A reagent in thematerial of the T member or added to it after insertion could initiateor catalyze the reaction of a hardenable material, e.g. a cyanoacrylateadhesive. Various materials and configurations for this function aredescribed in the parent application, Ser. No. 10/698,148.

Other enhancements can be applied to the T-tag fasteners describedherein and those described in the parent application, Ser. No.10/698,148 and provisional 60/613,917. For example, the T member of theT-tag fastener can be configured to minimize pressure concentrations onthe tissue. When applied by direct insertion, the T member of the T-tagfastener can be configured to distribute forces over a larger surfacearea. For example, the T member can be configured as a disk, square,rectangle or other shape with a large surface area. For blind insertion,the T member of the T-tag fastener can be configured to expand afterinsertion through the tissue to distribute forces over a larger area.For example, the T member can expand to form a disk, square, rectangle,I, X, Y or other configuration with a large surface area, as describedherein (e.g. FIG. 55A-55H) and in the prior application. Alternativelyor in addition, to reduce the potential for erosion at the end of the Tin some clinical situations it could be beneficial for the ends of the Tto have increased dimensions or configurations (for example a round ballshape) to reduce pressure at the end of the T and/or increasedflexibility which will result in a reduction of the angle between thegastric wall and the ends of the T. This would reduce the forces betweenthe T and the gastric wall and therefore reduce the potential forerosion at the ends. Structures that could accomplish this could includetapered thickness or cross section to reduce the bending moment.Alternatively or in addition, changes in material properties such ashardness, bending modulus and/or elongation can accomplish the sameresult. For example the T near the stem could be of a material of adurometer such as Shore 65D or higher the material may change as onemoves out along the arms of the T transitioning through 55D/100 A to 90A durometer or lower. Rounding, smoothing and structures that otherwisedistribute forces over a larger area will also serve to reduce erosionat the ends of the T. A circular shaped T may be particularly desirableto reduce erosion.

All or a portion of the fastener can be coated and/or made with amaterial that will encourage tissue ingrowth to create a seal and topromote a strong and durable attachment. All or a portion of thefastener can be coated and/or made with a swellable material to create aseal and/or to spread out the force of attachment over a greater surfacearea, thereby reducing the pressure on the tissue. All or a portion ofthe fastener can be coated and/or made with a material that isbiodegradable or bioresorbable. Examples of such coatings materials aredescribed in the parent application, Ser. No. 10/698,148.

In some of the examples herein and in the prior application, the T-tagfasteners are placed transmurally or through a full thickness plication.In an alternate method, an intramural T-tag can be placed submucosally,preferably in the serosa, where the T member would anchor the suture.The T would have a structure that is all or partly biodegradable. Inthis way, for those applications in which the sleeve device is intendedto be removed after a sufficient amount of time depending on the needsof a particular patient, all or part of the T would degrade afterremoval of the sleeve device. Alternatively, the tension elements of theT-tags can be clipped off.

Following are descriptions of attachment devices and other means forsecuring an implantable device within the gastrointestinal system. Theimplantable devices and/or attachment means can be configured to avoidcausing excessive pressure within the tissue by having compliance thatis compatible with the gastrointestinal tissues where it is attached.Device compliance can also be important for providing a leak free sealbetween an implanted device and the tissue at the attachment point.Compliance can be provided in the radial or circumferential directionand/or in the vertical, axial or longitudinal direction. The device mayhave different compliance in different regions to be compatible with thetissue at the attachment point and at other portions of thegastrointestinal tract through which it runs. The device may havedifferent compliance in different directions to be compatible with thetissue at the attachment point while simultaneously achieving othergoals of the device. Compliance can be provided in a number of differentways. One way is by elastic or plastic deformation of the device and/orthe attachment means. Another way is by a mechanical decoupling thatallows relative movement between the device and the attachment points,and/or between the attachment points themselves, without transmittingexcessive force or pressure to the tissue.

In some clinical situations, it will be desirable to match compliancebetween the device and the tissue to which it is attached. In othersituations, based upon the clinical situations, it will be desirable toprovide a device with higher or lower compliance than the tissue toachieve certain objectives. For example, maintaining the position of theproximal end of an attached sleeve device will require a device that isrelatively noncompliant in at least the axial direction.

The implantable devices and/or attachment means described herein canutilize one or more of the following features to modify the compliance:

1) Highly-elastic materials (large amounts of stretch with low forces)

-   -   a) Composite structures with elastic or super-elastic portions

2) Pleated materials (minimal force until pleats straighten)

-   -   a) Similarly, other types of loose (gathered) or hanging (e.g.        dangling sutures) connections

3) Fenestrated structures (e.g. cuts or slits)

-   -   a) Can optionally use slidable overlapping elements to        reduce/eliminate leaks at the slits

4) Stretchable weaves or knits

-   -   a) Cylindrical and/or flat (e.g. an expandable or self-expanding        stent or fabric)

5) Elastic, hinged and/or slotted structures that allow relative motionof components

-   -   a) Can also use overlapping for leak control

6) Isolated or independent attachments

-   -   a) Attachments to the GI tissue that are not connected        -   i) They can initially be isolated and later connected        -   ii) They could be interfaced with another device in a manner            that does not restrict their relative motion (e.g. long            hanging tethers)

7) Combinations of the above

Other features may be incorporated in such structures such as:

1) Reinforcement at attachment points

-   -   a) e.g. incorporation of fabric in a molded elastic structure    -   2) Clips, hangers or other means for sleeve interface at        individual points    -   a) For both isolated coupled and decoupled interfaces

3) Materials that encourage ingrowth and/or overgrowth

4) Separation of the functions of attachment and sealing

-   -   a) To allow greater compliance at the attachment without        increasing leakage

5) Means to maintain a substantially constant restricted volume withinand between the device and stomach.

6) Through control of the degree and direction of device compliance.

Certain methods for the use of such structures include:

1) Treating the tissue at the GEJ to eliminate or minimize distention

-   -   a) Creation of fibrotic or scar tissue        -   i) Chemical, RF or other energy        -   ii) Permanent or temporary to allow healing/seasoning of the            attachment    -   b) Thereby reducing the requirement for a compliant cuff or        other attachment

2) Treating the tissue at the GEJ to increase tissue strength

-   -   a) Creation of fibrotic or scar tissue

3) Allowing time for a primary attachment to heal before implantationand attachment of one or more secondary devices e.g. a sleeve.

Preferably, the attachment cuff 260 is compliant in the radial directionso that expansion and contraction of the stomach and esophagus due tocontents and/or muscular action will not place additional, or actuallyreduce, stress on the attachment points. An elastomeric material, suchas silicone or polyurethane that provides approximately 150% or morestretch in the radial direction is preferred. At the same time, theattachment ring can have enough lateral rigidity to act as a mountingplatform for the gastrointestinal sleeve device and to resist downwardmovement due to the weight of the gastrointestinal sleeve device and itscontents and peristaltic traction on the sleeve. The lateral rigidity ofthe attachment ring can be enhanced with radially oriented bendingreinforcements, such as ribs or embedded reinforcement members.Alternatively, the attachment cuff can be flexible and compliant andother means such as hooks, sutures staples, etc., can be used for sleeveattachment.

Another strategy for avoiding excessive pressure on the gastric wall atthe attachment points is to reduce the weight that the device attachmentmust support. This can be accomplished with spiral or longitudinalreinforcement members and/or inflatable balloons for structural support,particularly in the gastric portion of the gastrointestinal sleevedevice, as described in the prior application. These features will helpto transfer some of the weight to other structures of the stomach suchas the antrum or the pylorus and will reduce the tension on theattachment at the GEJ. Likewise, additional attachments points at otherpoints in the stomach will help to reduce the tension on the attachmentat the GEJ. Attachment at the pylorus or other points in the stomachwill also provide an added measure of safety. If the primary attachmentat the proximal end of a sleeve device ever came unfastened, theseadditional attachment points would prevent the sleeve device frompassing through the pylorus and becoming lodged in the intestine.

Another strategy for avoiding excessive pressure on the gastric wall atthe attachment points is to provide an axially “floating” attachment forthe gastrointestinal sleeve device so that stress transferred to theesophageal or gastric walls can be minimized or controlled. For example,FIG. 56A illustrates another means for attaching a gastrointestinalsleeve device that uses a compliant expandable or self-expanding cuff orstent 274 within the patient's esophagus. The gentle expansion of thecuff 274 anchors it in the esophagus without placing undue pressure onthe tissues. One or more T-tag fasteners 276 or other fasteners may beused as an additional attachment means. Rather than being solidlyattached to the cuff 274, the proximal end of the gastrointestinalsleeve device 278 has a floating attachment so that that expansion andcontraction of the stomach and esophagus due to contents and/or muscularaction will not place additional stress on the attachment points. Oneexample of a floating attachment is to have an annular ridge 280 on theinside of the cuff 274 and a ring 282 on the proximal end of thegastrointestinal sleeve device 278. The ring 282 is sized so that itmerely rests on top of the annular ridge 280, but cannot be pulledthrough it. The annular ridge 280 supports the gastrointestinal sleevedevice, but it does not transfer any radial force from thegastrointestinal sleeve device,to the esophageal or gastric walls.Optionally, a metal coil or other type of spring 281 can be used tocouple the ring 282 and annular ridge 280, as shown in FIG. 56B. Ifdesired, the floating attachment can also be combined with otherfeatures to allow the gastrointestinal sleeve attachment to float orexpand and contract in the radial direction, as well as in thelongitudinal direction. Optionally, a proximal annular ridge 284 may beformed near the proximal end of the expandable cuff 274 to limitlongitudinal motion of the floating attachment in the proximaldirection. Other means, such as the fasteners described herein and thosedescribed in the prior patent application can be used in place of thecuff to fasten a floating attachment of this type at the GEJ.Furthermore, the connections depicted in FIGS. 56A-56B, regardless ofthe “floating” feature described above, illustrate attachments that canbe detached with minimal trauma to the surrounding tissue.

An alternate means of implementing an axial floating attachment usesvertically mounted isolated sliding attachment members can be used as anattachment structure for an implanted device. FIGS. 57A and 58A-58C showan example of vertically mounted isolated sliding attachment members 340in a patient's stomach. This allows a maximum of relative motion betweenattachments with a minimum of force resisting that motion. The slidingvertical attachment allows vertical motion similar to that achieved withthe floating attachment shown in FIGS. 56A-56B. Each of the isolatedattachment members 340 is attached to the wall with one or more T-tagfasteners 130 or other types of fasteners. Although FIG. 57A shows anattachment member 340 attached with two T-tag fasteners 130, attachmentof the attachment member 340 using one T-tag fastener 130 is alsocontemplated. Typically, 4-16 attachment members will be fastened aroundthe periphery of the esophagus or stomach in the vicinity of the GEJ.The length of the attachment members helps to distribute the attachmentforce or pressure exerted on the tissue. The attachment members could becompletely separate or they may linked to one another by high compliancemembers or a membrane that would help to position and orient the membersfor attachment, but that would allow the members to float like separateattachment points. The linking members or membrane may be configured toencourage ingrowth/overgrowth for attachment and sealing. Alternatively,the device that is mounted on the attachment members may provide a sealagainst the gastric mucosa.

Once the attachment members 340 have been fastened to the stomach wall,the implantable device 120 is connected to them using a like number ofsliding connectors 341 attached to the implantable device 120. Thesliding connectors 341 are configured to allow vertical movement of theimplantable device 120 with respect to the attachment members 340 andthe stomach wall. Stops or detents may be included to limit the verticalmovement of the implantable device 120. In the example shown, thesliding connectors 341 are configured as channels that are slidablyconnected to rail-shaped attachment members 340. Other configurations ofattachment members 340 and sliding connectors 341 are also possible.

FIG. 57B shows an example of a vertically mounted isolated hookattachment member 440 in a patient's stomach. The hook attachment member440 is adapted to be attached to the stomach wall using T-tag fasteners130 or other fasteners discussed herein. The hook attachment member 440is adapted to engage complementary latching structures 450, such asloops or recesses, attached to or formed in the proximal end of thesleeve device 460. The hook attachment member 440 may be constructed sothat it can be releasably secured to the complementary latchingstructure 450 such as the loop shown in FIG. 57B, for example byconstructing the distal tip of the hook 440 so that it curves around thelatching structure 450 such that the hook 440 will not disengage fromthe latching structure 450 during normal movement of the stomach. Thehook attachment member 440 and complementary latching structure 450 mayalso be constructed to be releasable with minimal trauma to surroundingtissues when desired. Alternate embodiments of releasable connectionscomprising locking or securable attachment members or surfaces attachedto the stomach wall and complementary engaging structures attached tothe sleeve device are also contemplated. Alternatively, the attachmentmembers or surfaces, such as hooks, may be attached to the sleevedevice, while the complementary engaging structures are attached to thestomach wall.

The use of isolated attachments to attach a sleeve within the GI tracthas been previously disclosed herein and in parent application, Ser. No.10/698,148. Isolated attachment allows a maximum of relative motionbetween attachments with a minimum of force resisting that motion. Ashas been discussed, the attachments can be left in place for a time toheal and become secure prior to the attachment of a sleeve. This conceptcan be extended to the use of a cuff, which interfaces a replaceablesleeve with GI tissue. Isolated attachments can be placed in the GItissue, a period of time can allow healing of these attachment pointsand then the reusable cuff can be fastened to the GI tissue using thepreviously placed isolated attachments.

FIGS. 59 and 60 show one manner by which larger gastric wall motion canbe accommodated by forming the device/gastric wall interface in acompliant manner. This can be a compliant device or a means by which thedevice can move to minimize motion relative to the tissue. Specifically,as tissue moves, the device would move with the tissue rather thanresist the motion, which could lead to mucosa/device separation.However, device motion could be limited to the ability of the mucosa tomaintain its integrity.

FIG. 59 shows a compliant attachment ring device 300 for use with T-tagfasteners or other types of fasteners. The attachment ring device 300creates a plication (fold) and then controls the force to maintain theplication against the forces in the plicated tissue that would tend tostraighten the fold. In FIG. 59 the attachment ring device 300 is shownin a normal resting position, flexible or compliant upper 302 and lower304 flanges on the ring help maintain the shape of the plication. FIG.60 shows the compliant attachment ring device 300 with tension exertedon the tissue at the tissue/device interface. The flexible or compliantupper 302 and lower 304 flanges on the ring open up to compensate forthe tension, which reduces the force seen at the attachment points. Whenthe tension is reduced, the compliant attachment ring device 300 willreturn to its normal resting position.

FIGS. 61A-61B show another embodiment of a flexible attachment cuffdevice 450. The attachment device 450 has a generally cylindrical outerwall 452 with an inward-facing lower flange or ridge 454, and theupstream end of the gastrointestinal sleeve device 458 has acorresponding outward-facing upper flange or ridge 456. This embodimentof the attachment device is preferably formed of a flexiblebiocompatible polymer such as silicone or polyurethane, which mayoptionally be reinforced with Dacron or other fabric. The material isoptionally coated as described herein for encouraging ingrowth and/orresisting the attack of gastric secretions. All or a portion of thetissue contacting surfaces may be made from or covered with a materialthat encourages tissue ingrowth.

The attachment device 450 is passed through the esophagus and attachedto the stomach wall, preferably near the GEJ. The attachment device mayinclude a sewing ring or other features, such as those described herein,to facilitate attachment to a plication or directly to the unplicatedstomach wall. The gastrointestinal sleeve device 458 is then passedthrough the esophagus and into the stomach and intestine. The upperflange 456 on the sleeve device 458 is held by the lower flange 454 ofthe attachment device 450. Optionally, the upper flange 456 on thesleeve device 458 may have a sliding fit with the cylindrical outer wall452 to allow for relative motion between the sleeve device 458 and theattachment device 450, with the lower flange 454 on the attachmentdevice 450 serving to limit the downward motion of the sleeve device458. The sliding fit will help to reduce the tension transferred to thegastric wall from the sleeve device 458 and the weight of its contents.

In general, a first retention surface such as an upwardly facing surfaceon a radially inwardly facing flange or plurality of tabs on theattachment device (cuff) 450 limits distal movement of the sleeve bycontacting a second retention surface on the sleeve. The secondretention surface may be a downwardly (distally) facing surface such asthe distal surface of a radially outwardly facing annular flange orplurality of tabs on the proximal end of the sleeve. In thisconfiguration, the sleeve may be passed through the cuff and simply“dropped” into place and the first and second retention surfaces limitfurther distal travel of the sleeve relative to the cuff.

Alternatively, the attachment device may include an interlock or snapfit structure for capturing the upper flange of the sleeve device toreduce or eliminate relative motion between the sleeve device and theattachment device in either the proximal or distal direction. FIGS.62A-62B show an embodiment of the attachment device 460 with aninward-facing lip 462 above the lower flange 464 to releasably capturethe upper flange 456 of the sleeve device 458. Preferably, theinward-facing lip 462 has a sloped or tapered upper surface to create asmooth transition between the diameter of the attachment device 460 andthe sleeve device 458 and to avoid creating an inner shelf that couldcatch food before it enters the sleeve device 458. The attachment device460 may include an attachment ring or other features, such as thosedescribed herein, the referenced provisionals, and the parentapplications, to facilitate attachment to a plication or directly to theunplicated stomach wall.

FIGS. 63A-63B show another embodiment of the attachment device 470 withan annular groove 472 above the lower flange 474 for capturing the upperflange 456 of the sleeve device 458. This geometry allows the innerdiameter of the attachment device 470 to be matched to the innerdiameter of the sleeve device 458, with no internal steps. Theattachment device 470 may include a attachment ring or other features,such as those described herein, the referenced provisionals, and theparent application to facilitate attachment to a plication or directlyto the unplicated stomach wall.

In other variations of these embodiments, the cylindrical walls cantaper inward for attaching an implant device with a smaller diameterthan the attachment device or they can taper outward for attaching animplant device with a larger diameter than the attachment device.

Each of these embodiments permits the sleeve to be dropped into place orsnap fit into place by elastic or other deformation of the interlockingretention surfaces. The attachment can be made more secure by theaddition of one or two or more staples, stitches of suture or t-tags.Removal can be accomplished using a removal tool with a stop surface forplacing against a surface on the cuff to prevent proximal movement ofthe cuff, and a grasper for grasping the proximal end of the sleeve andpulling the sleeve to release it from the cuff without straining theconnection between the cuff and the tissue. Any additional sutures canbe snipped using conventional endoscopic cutting tools. The cuff mayalso be removed if desired, or a different sleeve may be introduced andsecured to the cuff.

The flexible cylindrical attachment device 480 can be constructed from anumber of materials and methods. By way of example, FIG. 64 is a cutawaydrawing showing the internal construction of a cylindrical attachmentdevice 480 made from woven or knitted material. The cylindrical wall 484can be woven or knitted in the round or it can be sewn into acylindrical configuration from one or more pieces of material. Thecylindrical wall 484 is preferably supported with a resilientwire-reinforced or elastic filamentous ring 486 at the upper and/orlower ends. The upper edge 482 of the cylindrical wall 484 is optionallyrounded or flared outward to minimize contact pressure on the gastricwall as described in the examples above above. A third wire-reinforcedring 488 may be provided at the lower end for attachment of agastrointestinal sleeve device or other implanted device. Alternatively,a molded upper and/or lower flange or other features can be attached tothe lower support ring for attaching a gastrointestinal sleeve device inthe manner described above.

In some clinical circumstances, it may be desirable to implant atreatment device that is larger than the attachment means. FIG. 65 showsan attachment device 420 fastened in the vicinity of the GEJ. At theupstream end of the attachment device 420 is an attachment ring 422 thatfastens to the gastric and/or esophageal wall, for example using theapparatus and methods described herein. Suspended below the attachmentring 422 is a gastrointestinal sleeve device 428 for treatment ofobesity. The entry of the gastrointestinal sleeve device 428 has alarger diameter than the attachment at the GEJ. To accommodate this, theattachment device 420 has an outward-tapering skirt 424 extendingdownward from the attachment ring 422. At the bottom edge of theoutward-tapering skirt 424 is a device attachment ring 426 or otherattachment means for fastening the upstream end of the gastrointestinalsleeve device 428 to the attachment device 420. Preferably, theoutward-tapering skirt 424 is made of an impermeable material so thatthe attachment device provides a fluid-tight seal between the attachmentpoint to the patient and the gastrointestinal sleeve device 428.

Alternatively, the attachment device can provide only a mechanicalattachment and the gastrointestinal sleeve device can provide a sealagainst the gastric wall or a separate sealing device may be provided.In this case, instead of an impermeable skirt, the attachment device mayhave a suspension frame that provides a mechanical attachment betweenthe attachment ring and the gastrointestinal sleeve device. Thesuspension frame may be made, for example, from wires or mesh orfilaments that provide the necessary mechanical strength, but do notprovide a seal. The skirt portion of the attachment device may also beconstructed with an impermeable membrane over a suspension frame of thistype. Optionally, the suspension frame may include adjustable lengthtethers for adjusting the distance between the attachment ring and thegastrointestinal sleeve device.

Preferably, the entire structure of the attachment device 420 iscollapsible and expandable so that it can be easily passed through theesophagus in a folded, compressed or collapsed state and re-expandedonce it is in the patient's stomach. Optionally, the final expandeddiameter may be adjustable. Optionally the device 420 may be highlycompliant and stretchable where it is attached to the gastric wall.

Although this example shows the implanted device mounted downstream orbelow the attachment device, in some clinical situations it may bedesirable to mount an implant device so that it protrudes above theattachment device.

External Sleeve Interface

With (1) a device system where a primary attachment such as a cuff isplaced in a tubular duct, e.g. at the GEJ, and a secondary device suchas a gastrointestinal sleeve is removably attached to the primaryattachment device and (2) placement of the system with a coaxialprocedure, e.g. an endoscope passed down the esophagus, placement of thesecondary device within the lumen of the primary device can be a simplerapproach. However, certain advantages could be obtained if the secondarydevice were mounted on the exterior of the primary device. Varioussleeve geometries with the sleeve portion of the interface being smallerdiameter and internally coaxial to the cuff have been previouslydescribed.

All of the configurations can be inverted such that the sleeve is oflarger diameter and external to the cuff. Similarly, other interfacedesigns such as hooks and eyes disclosed herein can be configured withthe sleeve of a larger diameter than the primary mounting cuff. FIG. 66illustrates an attachment cuff 550 with an external sleeve attachmentinterface. One of the potential advantages of mounting the sleeve 552external to the cuff 550 is that such a configuration could be designedto be robust in resisting leaks.

If the proximal portion of the sleeve 552 were less compliant than thedistal portion of the cuff 550, internal pressure would press the wallof the cuff 550 into sealing contact with the sleeve 552. In thissituation, the seal will be maintained so long as the sleeve 552stretches less than the cuff 550 as internal pressure increases. Alsothe distance the cuff 550 and the sleeve 552 overlap can be adjusted toimprove interface performance related to leak resistance and/orretention strength. This system can also allow holes or perforations ineither the cuff or sleeve in the region of overlap of an unperforatedsurface without allowing leaks. These holes or perforations may be usedto attach the components. The sleeve 552 is removably connected to thecuff 550. Alternate removable connections between the sleeve 552 and thecuff 550, such as stitching, stapling, T-tags, hooks and loops includingVelcro, magnetic interfacing structures, adhesives, frictioninterfitting structures, and various other complementary interfittingstructures, depending on the desired performance, are contemplated.

Separation of Attachment and Sealing

The functions of attachment and sealing can be separated, for examplehighly compliant attachment can be placed at the GEJ and a sealingconnection can be placed upstream towards the esophagus. The compliantattachment can be accomplished with gathered or pleated stretchablematerial. The sealing connection can be configured similar to a coveredexpandable or self-expanding stent. These separate structures can beimproved by structure (e.g. one or more vertical bellows-like pleats)that would allow relative vertical displacement of the sealing andattachment zones.

FIG. 67 illustrates an attachment cuff or gastrointestinal sleeve 560with separation of the attachment and sealing functions. A sealing zoneis created, for example using an expandable or self-expanding stent 562or a compliant material cuff attached with T-tag fasteners. Theattachment cuff or gastrointestinal sleeve 560 is attached to thegastric wall downstream of the sealing zone, for example using elongatedtethers 564 with transmural T-tags 566. Preferably, the attachment cuffor gastrointestinal sleeve 560 is configured to allow some longitudinalcompliance between the sealing zone and the attachment zone. In theexample shown, one or more accordion folds 568 create a zone oflongitudinal compliance between the sealing zone and the attachmentzone.

Distal Compliance

Similarly, the restrictive component of a morbid obesity treatmentsystem has usually been depicted as being at or distal to the attachmentpoint of the device. Since restrictions may be most effective whencoupled with a constant or restricted volume proximal to the restrictionthis suggests that little or no compliance would be preferred at theattachment. Alternatively, the compliance of the attachment can befactored into the definition of the restricted volume. In some clinicalsituations where high compliance is desirable it could be preferable forthe restricted outlet of the restricted volume be placed proximal to acompliant attachment e.g. attachment 562 in FIG. 67. This can allowsignificant displacement of the compliant attachment without changing(increasing) the restricted volume proximal to the restricted outlet.

Compliant attachment means can be used at or near the GEJ or cardia ofthe stomach. These attachments can be connected to a restrictivecomponent, which is maintained in a sealing connection with the walls ofthe GI tract proximal to the attachment. The means used to connect therestrictive component (a device that has a restrictive opening and sealswith the walls of the GI tract) do not need to be impervious tomasticated food. Sealing means can be passive (for example, an oversizeddevice in a relatively smaller tubular duct) or active (for example,suture, anchor, staple, etc.) However, this sealing is not the primaryattachment. It is merely to maintain a seal while the primary compliantattachment resists other forces.

Tissue Prestrengthening

In some clinical situations the gastroesophageal junction, or GEJ, is apreferred attachment point for a gastroesophageal sleeve device orattachment device as discussed above. Attachment at the GEJ excludes allgastric secretions from the interior of the gastrointestinal sleevedevice to separate ingested food and liquids in the sleeve device fromall digestive secretions. The gastroesophageal junction is one of thepreferred attachment sites because the tissue wall is relatively thickat this location and it is relatively easy to access via a peroralroute. More specifically, the non-glandular tissue directly above thesquamo-columnar junction (a zone of tissue that is considered to be atthe beginning of the GEJ) is the strongest tissue in this region and iscurrently thought to be the best place to attach a device, for exampleusing T-tags, sutures or other fasteners.

In some clinical situations it may be beneficial to prestrengthen thetissue prior to implantation of a device such as a gastrointestinalsleeve device. For example, energy can be delivered in the form of RF,ultrasound or other known method to induce an inflammatory, coagulativeor necrotic tissue strengthening reaction. Alternatively, placement ofmaterial in the serosal tissue of the stomach wall could generate aforeign body reaction that would progress from inflammation, togranulation of tissue and then to fibrosis. The tissue may initiallyweaken due to the inflammatory response, but the resulting fibroticgrowth will strengthen the tissue. This effect could be enhanced by thechoice of material an/or coatings, e.g. sclerosing agent, an acidicmaterial or coating. The materials could be delivered endoscopicallywith a needle device through the biopsy channel of an endoscope. Theneedle delivery device could optionally also deliver an ink, dye orother marking means to facilitate location of the prestrengthened areas.Tissue reaction could take place in days, with 7-14 days being anapproximate delay between prestrengthening and attachment procedures.FIGS. 68-69 show examples of tissue prestrengthening in thegastrointestinal system. In FIG. 68, the material 500 has been deliveredinto the gastric wall just under the mucosa 504. The granulation andfibrosis 502 start at this point and progress through the muscularis 506to strengthen the tissue and prepare it for attachment of an implantabledevice. In FIG. 69, the material 500 has been delivered deeper into thegastric wall close to the serosa 508. The granulation and fibrosis 502start at this point and progress through the muscularis 506 tostrengthen the tissue and prepare it for attachment of an implantabledevice. Optionally, tissue prestrengthening can be accomplished byinserting a fibrosis inducing agent with a suture tail attached to it toallow it to be retrieved or used to guide a subsequent attachment to theprestrengthened location after it has had the desired affect on thetissue wall.

Material injectable to prestrengthen tissue could be: 1) liquid wherenatural processes would remove/break down or otherwise dispose of theliquid when it has completed its function; 2) biodegradable ordissolvable where natural processes would remove the material when ithas completed its function; or 3) permanent where the material might beincorporated into the tissue to provide increased strength. All of theprestrengthening strategies described could be used at the time of theattachment procedure to enhance strength of the attachment.

The methods and apparatus described for tissue strengthening would beexpected to result in some degree of tissue thickening as new collagenand fibrotic material will be deposited and/or generated at the locationof the foreign body reaction. The duration of exposure can be controlledby use of timed release chemical stimulants and stimulants with knownand potentially controllable half lives. Tissue thickening and tissuestrength may be related and may facilitate durable attachment, howevertissue thickening may be an inherently desirable result in some clinicalsituations. FIG. 70 shows an example of tissue thickening in thegastrointestinal system as a result of a material 500 injected ordelivered into the gastric wall. Optionally, a suture or other filament512 may be connected to the material to allow it to be retrieved or usedto guide a subsequent attachment to the prestrengthened location afterit has had the desired affect on the tissue wall and to halt additionaltissue thickening.

Currently, tissue bulking agents are injected at or near the GEJ totreat GERD. Injection of non-bulking materials that initiate tissuethickening could accomplish the same end result. If the thickened tissuewas, by itself or in conjunction with a supporting structure, to form arestrictive stoma, there could be specific advantages relative to amechanical stoma. FIG. 71 shows an example of tissue thickening in thegastrointestinal system using a bulking material 510 injected ordelivered into the gastric wall.

Tissue prestrengthening and/or thickening can be accomplished byinserting a fibrosis inducing agent with a suture tail attached to it.The fibrosis inducing agent will preferably also act as a scaffold forstrength. The tail will allow easy identification of the location thathas been strengthened for retrieval or guidance of follow on attachmentprocedures. Once tissue has strengthened, cuff and sleeve can be placedin a single combined procedure as the prestrengthened tissue will notrequire additional healing time to hold.

Other approaches to induce tissue prestrengthening and/or thickeninginclude: Circumferential ablation (RF, microwave, ultrasound, etc);Over-dilation; Circumferential abrasion; and, Circumferential exposureto agent. An advantage of a circumferential area of tissue strengtheningis that it only needs to be located along a vertical axis for subsequentattachment procedures.

Alternately or in addition to the above pre-strengthening of tissue,tissue can be treated to reduce its ability to move or stretch. This canbe advantageous in that tissue that has limited stretch or motion mayhave less impediments to attachment. Tissue that has limited stretch ormotion may impose fewer forces on an attached device and thereforeimpose less pressure that may lead to attachment failure. Furthermore,tissue that has limited stretch or motion may allow attachment of lesscompliant devices which can provide for advantages foe examplesimplified sealing.

Techniques described above to strengthen tissue can also help to limitedGI tissue stretch and motion. Other methods that could be applied toreducing stretch and motion, and also for pre-strengthening, include theapplication of energy for example, by RF, ultrasound or laser. Meansthat include time release elements as well known in the art of drugeluting vascular stents and birth control devices can be used to provideand/or maintain a long lasting effect (reducing motion and stretch).Such time release means can optionally be combined with fasteners,permanent or replaceable attachment cuffs or proximal sleeve interfaces.Such time release means can optionally be combined with permanentlyimplanted pre-strengthening materials where the material might beincorporated into the tissue to provide increased strength.

Suture Lengthening

In some clinical situations when using a transmural attachment, the wallof tissue may thicken after placement of the attaching device. FIGS.72A-72C show schematically the effect of tissue thickening on a fixedlength suture or fastener 520. In some cases this can progress toencapsulation. This thickening can result in increased tissue strengthdue to collagen deposition and/or fibrosis.

In some clinical situations it can be advantageous to maintain theattachment on the surface of the tissue to take advantage of the addedstrength of the thickened wall. FIGS. 73A-73C show controlled suturelengthening to compensate for tissue thickening. One manner in whichthis could be accomplished would be by using a suture 522 connecting theattachments 524 on either side of the tissue wall that would stretch asthe tissue thickens.

One configuration of material that could have advantageous performancewould: 1) not stretch for an initial period, for example 24-48 hours; 2)stretch at a relatively low force for the next period, for example 7-14days; then 3) not stretch after the second period. This performancewould be based upon a clinical situation where tissue proliferation(wall thickening) occurs between days 2 and 14. Alternatively, thematerial could: 1) not stretch for the initial period, for example 24-48hours; 2) allow lengthening to 2×length at any time after the initialperiod, for example 48 hours; then 3) not stretch beyond 2×length.

FIGS. 74A-74E illustrate an embodiment of a fastener with controlledsuture lengthening to compensate for tissue thickening. In this example,the fastener is configured to allow approximately 2×lengthening over acontrolled time period and then to resist further lengthening. This canbe accomplished as follows:

A portion of the suture 522 is folded at least about 2× or 3× as shownin FIG. 72A. A dissolvable or resorbable coating or adhesive 526 isadded to the overlapping portion of the suture 522 to initially resistlengthening after implantation as shown in FIG. 72B. The coating 526will dissolve or resorb after a predetermined period of time, releasingthe folded portion of the suture 522 as shown in FIG. 72C. Afterdissolution of the coating 526, the suture 522 will lengthen withoutsignificant resistance as shown in FIG. 72D. FIG. 72E shows the suture522 fully extended to its final length.

Lengthening could also be accomplished with a coaxial system. FIGS.75A-75B illustrate another embodiment of a fastener 530 with a coaxialsystem for controlled suture lengthening to compensate for tissuethickening. The fastener 530 has a linear inner member 532 and a tubularouter member 534 in a telescoping coaxial arrangement. Ports 536 in thetubular outer 534 member allow fluid entry. A stop or detent 538 at theends of the inner member 532 and outer member 534 prevent separation ofthe fastener 500. Similar to the system previously described, adissolvable or degradable material 540 can be used to controllengthening. By restricting or controlling exposure of the biodegradablematerial to body fluids, the rate of lengthening can be optionallycontrolled.

The principle of shortening/lengthening of a braided mesh can be appliedto an automatically lengthening suture. FIGS. 76A-76B illustrate anotherembodiment of a fastener 542 using this principle for controlled suturelengthening to compensate for tissue thickening. A dissolvable innercore 544 holds the braided mesh suture 546 open, keeping the fastener542 in a shortened configuration as shown in FIG. 76A. After the innercore 544 dissolves, the braided mesh suture 546 can lengthen as shown inFIG. 76B. Lengthening is accomplished by a change in angle of thebraided fibers as the inner core dissolves, allowing the diameter toshrink.

An optimized yielding suture system for GI attachment could havediffering responses to short impulse and long continuous loads.Viscoelastic polymer systems such as Tempurfoam resist short termimpulse loads and yield to slow steady long term loads. Resistance toshort term loads and yielding to long term loads could be advantageousin clinical situations where there can be temporary short term loadingdue to overeating while yielding to long term loads could relieveoverpressurization of tissue to enable tissue perfusion to avoid tissuenecrosis due to pressure and/or ischemia.

In other clinical situations yielding to short term transient loads mayfacilitate secure attachment when coughing, retching, swallowing etc.occur. Resistance and/or recovery in the face of lower and slower forcescan return the suture to a normal length, facilitating leak freesecuring of an attachment.

Yield points and/or recovery points should be selected so attachmentforces do not exceed the acute pull out force of a suture and/or T-tag.Acute pull out forces can be in the range of 3-9 pounds depending on thesuture/T-tag configuration. This is of particular concern for short termimpulse loads. Loads applied over longer periods should be selected toavoid ischemia and/or pressure necrosis. These forces can be very lowand can be less than 1 pound.

In an ideal situation, a suture system will recover to a set lengthwhich results in no force applied to the tissue over extended periods oftime. Attachment can resist forces between necrosis force/pressure ifthey are transient and allow tissue time for healing and/or recovery. Asystem whereby recovery after yielding occurs in a non-continuous mannerthereby allowing tissue healing and/or recovery could be desirable inmany clinical situations. This may be accomplished by materials thatrespond to outside stimulus (e.g. electrical, chemical, magnetic, etc.)that can be applied intermittently.

The length of the suture or other tension element which extends throughthe wall from the serosal surface to the mucosal surface, particularlywhen the tension element has a substantially fixed length under normaluse conditions may also be important. The present inventors believe thatthe length of the tension element is in certain applications at leastabout 75%, often at least about 100%, and preferably at least about 120%and possibly at least about 130% of the thickness of the wall of thestomach through which the tension element is to be placed. Thus, for apatient having a wall thickness in the vicinity of the gastroesophagealjunction of approximately 10-15 mm, suture lengths between the mucosalcontacting surface of the implant and the serosal contacting surface ofthe retention element of at least about 10 mm, and often at least about15 mm are contemplated.

The stomach appears to have unusual abilities to isolate foreignobjects. Evidence of this is the lap band which can migrate from theserosal surface of the stomach into the lumen of the stomach without anyimmediate catastrophic event such as a leak of stomach contents into thebody cavity which could be life threatening. The cause of such erosionis unclear but one theory suggests it is at least in part due topressure.

The stomach is also a very active organ with an ability to stretch,compress, churn and move laterally relative to itself. This activity isnormal in eating and digestion and can also function to isolate foreignobjects.

These anatomical aspects make attachment of medical devices to thestomach quite challenging. A recent study at the Cleveland Clinic whichsutured a prosthetic cuff to the GEJ showed that by 7 days 80% of thecuffs had become primarily detached. In one animal that was survived fortwo months, the device remained attached at 4 weeks but was only 25%attached by 60 days.

The present inventors have conducted a series of studies to explore theparameters of a successful attachment. Initial designs utilizing rigidrings lost attachment at a majority of points within four weeks.

Short term success at two weeks with a flexible cuff, with elasticability, was achieved by using t-tags and placing them in thenon-glandular tissue region of the GEJ.

However this same technique at five weeks did not maintain 100%attachment. One-Third of the attachment points migrated through thestomach, leaving no identified histological evidence of their path. Thet-tags did not appear to be deformed.

The inventors then undertook a series of experiments at five weekscontrolling for the amount of tension on the tension element, by placingserosal surface attachment devices having tension elements with apredetermined length relative to the thickness of the tissue wall. Thethickness of the porcine stomach at the target site was measured, andthe average of four tissue thickness measurements at the 3-6-9-12o'clock positions was used as the nominal thickness. The absolutethickness was somewhat surprising at around 1 cm. This was perceived tobe much thicker than what was thought. The reasons for this could beincreased thickness in the area of interest of the GEJ, but it couldalso be due to the highly compressible nature of stomach tissue in thatwhen it is held between the thumb and index finger it does feel 1 cmthick.

In three experiments conducted there was a clear trend that the looserthe attachment (i.e., the longer the length of the tension elementcompared to the local wall thickness) the more attachment points held atfive weeks. Results ranged from 10/12 migrations for the sutures sizedat 50% of nominal thickness to 2/12 migrations for sutures sized at 100%of nominal thickness.

Another variable which was explored in the porcine model was the effectof changes in the surface area of the retention element. Siliconebuttons having a 1 cm diameter were used instead of the t-tags. In oneexperiment conducted to date at a suture length of 75% of nominalthickness, 4/12 silicone buttons migrated through.

What seemed different about the silicone buttons is with two-thirds ofthe attachments in place it appeared upon gross inspection to be verystrongly functionally attached, with high weight bearing abilities,perceptually greater than the t-tags.

From the experiments to date it appears that tension control is asimportant (if not more so) as the geometry of the serosal attachmentdevice.

As discussed elsewhere herein, tension control could be addressed byusing suture with limited elastic properties or other structuralmechanism that would stretch or elongate and then return to theirnominal length. Another way is to use an assumed thickness, based uponan average of actual measurements in humans, and preset the length ofthe tension element at a predetermined length (e.g., at least 115%, atleast 130%) compared to the length of the average. The chances ofsuccess for this approach would likely be enhanced if the patient topatient variation is relatively small. A further approach would be tomeasure the thickness of the target tissue in each patient, andcustomize the length of the tension element at the clinical site, orprovide kits with a cuff and an array of anchor assemblies with tensionelements of different predetermined lengths from which the clinician canmake a selection. Measurement could be accomplished, for example, withendoscopic ultrasound, like a device available from Boston Scientific.

Once the measurement is taken a variety of devices could be used toattach with a controlled length. Many of these devices have beenpreviously described and include t-tags, inflatable silicone discs,molly type devices, radial spoke “umbrella” structures and others. Theycan be attached to suture with a fixed cuff to retention element length(or other means) or a strut member made of polymer or metal with a nubto fix the length. All of these devices are preferably configured topermit endoscopic delivery through a single fire device, or a multiplefire or rapid reloadable device could be used, to minimize the number oftimes the delivery device needs to removed from the endoscope to bereloaded.

In order to facilitate holding the cuff in place while attaching, thecuff could come preloaded on a radially expanding support structure thatcan be removed following implantation. Or it could be held in place by adeflectable alligator clip or other grasping device that would hold thecuff against the GEJ at the target site.

U.S. patent application Ser. No. 10/698,148 describes gastric andgastrointestinal sleeve devices that include inflatable balloons forstructural support of the sleeve and/or for enhancing the patient'sfeeling of satiety. An enhanced method of using these devices is toinflate the balloons with a fluid containing a nontoxic detectable dye,such as methylene blue. If any of the inflatable balloon members shoulddevelop a leak, the methylene blue will be passed in the urine and bedetectable by the patient. The patient should then contact a physicianto determine whether repair or replacement of the device is indicated.

Another concept described in the Ser. No. 10/698,148 applicationinvolves the placement of a mounting ring or other attachment devicewithin the gastrointestinal system and attaching various other devicesor components to the attachment device. Enhancements to that concept fortreating GERD, MO and other disorders of the gastrointestinal tractcould include placing/attaching a nonrestrictive mounting ring at ornear the GEJ and attaching/removing/replacing various therapeutic ordiagnostic devices to the mounting ring, such as a valve to preventreflux, a restriction to food intake, a sleeve, a telemetry or imagingcapsule, etc.

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary skill in the art thatmany modifications, improvements and subcombinations of the variousembodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof.

1. A method of adjusting therapy in a patient, comprising the steps of:identifying a patient with an implanted first gastrointestinal bypasstube having a first length, the first bypass tube releasably connectedto a support which is attached to tissue in the vicinity of thegastroesophageal junction; separating the first bypass tube from thesupport and removing the first bypass tube from the patient; providing asecond bypass tube, having a second length which is different than thefirst length; and attaching the second bypass tube to the support.
 2. Amethod of adjusting therapy in a patient as in claim 1, wherein thesecond length is longer than the first length.
 3. A method of adjustingtherapy in a patient as in claim 1, wherein the second length is shorterthan the first length.
 4. A method of adjusting therapy in a patient asin claim 1, wherein the attaching step is accomplished endoscopically.